Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT00394706
Status:
TERMINATED
Last Update Posted:
2018-08-09
First Post:
2006-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spes@uw.edu', 'phone': '206-685-1302', 'title': 'Siobhan Brown, PhD-Biostatistician', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Analyze Early + ITD', 'description': 'Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.', 'otherNumAtRisk': 2310, 'otherNumAffected': 0, 'seriousNumAtRisk': 2310, 'seriousNumAffected': 154}, {'id': 'EG001', 'title': 'Analyze Early + Sham', 'description': 'Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.', 'otherNumAtRisk': 2321, 'otherNumAffected': 0, 'seriousNumAtRisk': 2321, 'seriousNumAffected': 193}, {'id': 'EG002', 'title': 'Analyze Early, Not in ITD vs Sham', 'description': 'Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.', 'otherNumAtRisk': 2051, 'otherNumAffected': 0, 'seriousNumAtRisk': 2051, 'seriousNumAffected': 122}, {'id': 'EG003', 'title': 'Analyze Later + ITD', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.', 'otherNumAtRisk': 2156, 'otherNumAffected': 0, 'seriousNumAtRisk': 2156, 'seriousNumAffected': 166}, {'id': 'EG004', 'title': 'Analyze Later + Sham', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.', 'otherNumAtRisk': 2191, 'otherNumAffected': 0, 'seriousNumAtRisk': 2191, 'seriousNumAffected': 174}, {'id': 'EG005', 'title': 'Analyze Later, Not in ITD vs. Sham', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.', 'otherNumAtRisk': 1839, 'otherNumAffected': 0, 'seriousNumAtRisk': 1839, 'seriousNumAffected': 121}, {'id': 'EG006', 'title': 'Not in AEvAL, ITD Device', 'description': 'Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.', 'otherNumAtRisk': 1336, 'otherNumAffected': 0, 'seriousNumAtRisk': 1336, 'seriousNumAffected': 181}, {'id': 'EG007', 'title': 'Not in AEvAL, Sham', 'description': 'Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.', 'otherNumAtRisk': 1278, 'otherNumAffected': 0, 'seriousNumAtRisk': 1278, 'seriousNumAffected': 152}], 'seriousEvents': [{'term': 'Airway bleeding', 'notes': 'Finding of frank blood or bloody fluids in the airway secretions, the oro- or naso-pharynx region, or the advanced airway by EMS or ED/hospital personnel.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2310, 'numEvents': 64, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 2321, 'numEvents': 79, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 2051, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 2156, 'numEvents': 67, 'numAffected': 67}, {'groupId': 'EG004', 'numAtRisk': 2191, 'numEvents': 69, 'numAffected': 67}, {'groupId': 'EG005', 'numAtRisk': 1839, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG006', 'numAtRisk': 1336, 'numEvents': 61, 'numAffected': 60}, {'groupId': 'EG007', 'numAtRisk': 1278, 'numEvents': 51, 'numAffected': 51}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2310, 'numEvents': 99, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 2321, 'numEvents': 121, 'numAffected': 120}, {'groupId': 'EG002', 'numAtRisk': 2051, 'numEvents': 98, 'numAffected': 98}, {'groupId': 'EG003', 'numAtRisk': 2156, 'numEvents': 104, 'numAffected': 104}, {'groupId': 'EG004', 'numAtRisk': 2191, 'numEvents': 118, 'numAffected': 118}, {'groupId': 'EG005', 'numAtRisk': 1839, 'numEvents': 101, 'numAffected': 99}, {'groupId': 'EG006', 'numAtRisk': 1336, 'numEvents': 135, 'numAffected': 134}, {'groupId': 'EG007', 'numAtRisk': 1278, 'numEvents': 109, 'numAffected': 108}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Defibrillator burns to chest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2310, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2051, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1839, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1278, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver lacerations', 'notes': 'Liver lacerations secondary to CPR with bleeding and hypotension.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2310, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2321, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2051, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1839, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1278, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5290', 'groupId': 'OG000'}, {'value': '4643', 'groupId': 'OG001'}, {'value': '4373', 'groupId': 'OG002'}, {'value': '4345', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Analyze Early', 'description': 'Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG001', 'title': 'Analyze Later', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG002', 'title': 'Active ITD', 'description': 'Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.'}, {'id': 'OG003', 'title': 'Sham ITD', 'description': 'Sham ITD used by EMS providers in the pre-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}, {'value': '260', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.7', 'pValueComment': 'Two sided test with an a priori threshold of 0.05 for declaring statistical significance.', 'estimateComment': 'Estimate of the rate of MRS \\<= 3 in Analyze Later arm minus rate in Analyze early arm.', 'groupDescription': 'Comparison of the rates of MRS \\<=3 in Analyze Early vs. Analyze Later arms using a linear mixed effect model with an identity link and random effects to account for the cluster randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.71', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.8', 'pValueComment': 'To adjust for group sequential monitoring, the point estimate was bias-adjusted (Whitehead 1986) and confidence intervals and P values calculated from the maximum likelihood based ordering of the outcome(Emerson and Fleming, 1990)', 'estimateComment': 'Estimate of the rate of MRS \\<= 3 in the active ITD arm minus the rate in the Sham ITD arm.', 'groupDescription': 'Comparison of the rates of MRS \\<=3 in Active ITD and Sham treatment arms, adjusted for sequential monitoring.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Hospital discharge or death prior to discharge', 'description': 'The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.'}, {'type': 'SECONDARY', 'title': 'Survival to Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5290', 'groupId': 'OG000'}, {'value': '4643', 'groupId': 'OG001'}, {'value': '4373', 'groupId': 'OG002'}, {'value': '4345', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Analyze Early', 'description': 'Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG001', 'title': 'Analyze Later', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG002', 'title': 'Active ITD', 'description': 'Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.'}, {'id': 'OG003', 'title': 'Sham ITD', 'description': 'Sham ITD used by EMS providers in the pre-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}, {'value': '357', 'groupId': 'OG002'}, {'value': '355', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '1.1', 'pValueComment': 'Two sided test with an a priori threshold of 0.05 for declaring statistical significance.', 'estimateComment': 'Estimate of the rate of survival to hospital discharge in Analyze Later arm minus rate in Analyze early arm.', 'groupDescription': 'Comparison of the rates of survival to hospital discharge in Analyze Early vs. Analyze Later arms using a generalized estimating equations model with an identity link, grouping on cluster.', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.99', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '1.1', 'estimateComment': 'Estimate of the rate of survival to hospital discharge in the active ITD arm minus rate in the Sham ITD arm.', 'groupDescription': 'Comparison of the rates of survival to hospital discharge in Active ITD and Sham treatment arms.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Survival to hospital discharge or death before discharge', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.'}, {'type': 'SECONDARY', 'title': 'Modified Rankin Score at 6 Months After Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '223', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Analyze Early', 'description': 'Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG001', 'title': 'Analyze Later', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG002', 'title': 'Active ITD', 'description': 'Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.'}, {'id': 'OG003', 'title': 'Sham ITD', 'description': 'Sham ITD used by EMS providers in the pre-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.34', 'estimateComment': 'Mean MRS for Analyze Later minus mean MRS for Analyze Early (i.e. positive values favor Analyze Later).', 'groupDescription': 'Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.44', 'estimateComment': 'Mean MRS for Active ITD minus mean MRS for Sham ITD (i.e. positive values favor the active device).', 'groupDescription': 'Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months post hospital discharge', 'description': 'The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.'}, {'type': 'SECONDARY', 'title': 'Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}, {'value': '226', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Analyze Early', 'description': 'Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG001', 'title': 'Analyze Later', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG002', 'title': 'Active ITD', 'description': 'Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.'}, {'id': 'OG003', 'title': 'Sham ITD', 'description': 'Sham ITD used by EMS providers in the pre-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '18.0', 'spread': '6.3', 'groupId': 'OG002'}, {'value': '18.7', 'spread': '5.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.83', 'estimateComment': 'Mean ALFI-MMSE for Analyze Later minus mean ALFI-MMSE for Analyze Early (i.e. positive values favor Analyze Later).', 'groupDescription': 'Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '0.28', 'estimateComment': 'Mean ALFI-MMSE for Active ITD minus mean ALFI-MMSE for Sham ITD (i.e. positive values favor the active device).', 'groupDescription': 'Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months post hospital discharge', 'description': 'The adult lifestyle and function interview (ALFI) version of the mini-mental status exam (MMSE) measures neurological status. The ALFI-MMSE has 23 items. It is scored from 0 to 22, with lower scores interpreted as being worse.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.'}, {'type': 'SECONDARY', 'title': 'Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '189', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Analyze Early', 'description': 'Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG001', 'title': 'Analyze Later', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.'}, {'id': 'OG002', 'title': 'Active ITD', 'description': 'Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.'}, {'id': 'OG003', 'title': 'Sham ITD', 'description': 'Sham ITD used by EMS providers in the pre-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '0.75', 'spread': '0.33', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.05', 'estimateComment': 'Mean HUI for Analyze Later minus mean HUI for Analyze Early (i.e. positive values favor Analyze Later).', 'groupDescription': 'Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.05', 'estimateComment': 'Mean HUI for Active ITD minus mean HUI for Sham ITD (i.e. positive values favor the active device).', 'groupDescription': 'Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months post hospital discharge', 'description': 'The Health Utilities Index Mark 3 system was used to evaluate generic health related quality of life (HRQL). The interview-administered version of HUI3 requires completion of a maximum of 39 questions. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Analyze Early + ITD', 'description': 'Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.'}, {'id': 'FG001', 'title': 'Analyze Early + Sham', 'description': 'Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.'}, {'id': 'FG002', 'title': 'Analyze Early, Not in ITD vs Sham', 'description': 'Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.'}, {'id': 'FG003', 'title': 'Analyze Later + ITD', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.'}, {'id': 'FG004', 'title': 'Analyze Later + Sham', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.'}, {'id': 'FG005', 'title': 'Analyze Later, Not in ITD vs. Sham', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.'}, {'id': 'FG006', 'title': 'Not in AEvAL, ITD Device', 'description': 'Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.'}, {'id': 'FG007', 'title': 'Not in AEvAL, Sham', 'description': 'Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1819'}, {'groupId': 'FG001', 'numSubjects': '1862'}, {'groupId': 'FG002', 'numSubjects': '1624'}, {'groupId': 'FG003', 'numSubjects': '1633'}, {'groupId': 'FG004', 'numSubjects': '1636'}, {'groupId': 'FG005', 'numSubjects': '1384'}, {'groupId': 'FG006', 'numSubjects': '929'}, {'groupId': 'FG007', 'numSubjects': '851'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1815'}, {'groupId': 'FG001', 'numSubjects': '1860'}, {'groupId': 'FG002', 'numSubjects': '1615'}, {'groupId': 'FG003', 'numSubjects': '1632'}, {'groupId': 'FG004', 'numSubjects': '1634'}, {'groupId': 'FG005', 'numSubjects': '1377'}, {'groupId': 'FG006', 'numSubjects': '926'}, {'groupId': 'FG007', 'numSubjects': '851'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Clinical sites enrolled patients during a run-in period with the first patient enrolled on June 7, 2007. The run-in period ranged from from 2 to 6 months across the sites. The last patient was enrolled in the evaluable phase on November 6, 2009. All patients were enrolled in the pre-hospital EMS setting.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1817', 'groupId': 'BG000'}, {'value': '1861', 'groupId': 'BG001'}, {'value': '1621', 'groupId': 'BG002'}, {'value': '1631', 'groupId': 'BG003'}, {'value': '1633', 'groupId': 'BG004'}, {'value': '1379', 'groupId': 'BG005'}, {'value': '929', 'groupId': 'BG006'}, {'value': '851', 'groupId': 'BG007'}, {'value': '11722', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Analyze Early + ITD', 'description': 'Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.'}, {'id': 'BG001', 'title': 'Analyze Early + Sham', 'description': 'Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.'}, {'id': 'BG002', 'title': 'Analyze Early, Not in ITD vs Sham', 'description': 'Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.'}, {'id': 'BG003', 'title': 'Analyze Later + ITD', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.'}, {'id': 'BG004', 'title': 'Analyze Later + Sham', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.'}, {'id': 'BG005', 'title': 'Analyze Later, Not in ITD vs. Sham', 'description': 'Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.'}, {'id': 'BG006', 'title': 'Not in AEvAL, ITD Device', 'description': 'Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.'}, {'id': 'BG007', 'title': 'Not in AEvAL, Sham', 'description': 'Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '734', 'groupId': 'BG000'}, {'value': '809', 'groupId': 'BG001'}, {'value': '687', 'groupId': 'BG002'}, {'value': '693', 'groupId': 'BG003'}, {'value': '675', 'groupId': 'BG004'}, {'value': '590', 'groupId': 'BG005'}, {'value': '381', 'groupId': 'BG006'}, {'value': '370', 'groupId': 'BG007'}, {'value': '4939', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '1082', 'groupId': 'BG000'}, {'value': '1050', 'groupId': 'BG001'}, {'value': '932', 'groupId': 'BG002'}, {'value': '937', 'groupId': 'BG003'}, {'value': '954', 'groupId': 'BG004'}, {'value': '789', 'groupId': 'BG005'}, {'value': '547', 'groupId': 'BG006'}, {'value': '481', 'groupId': 'BG007'}, {'value': '6772', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age is not available for 8 ITD, 8 Sham, 11 Analyze Early, and 18 Analyze Later subjects.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '16.3', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '16.4', 'groupId': 'BG001'}, {'value': '66.3', 'spread': '17.0', 'groupId': 'BG002'}, {'value': '67.2', 'spread': '16.6', 'groupId': 'BG003'}, {'value': '67.1', 'spread': '16.4', 'groupId': 'BG004'}, {'value': '66.3', 'spread': '16.7', 'groupId': 'BG005'}, {'value': '67.7', 'spread': '16.3', 'groupId': 'BG006'}, {'value': '66.7', 'spread': '16.7', 'groupId': 'BG007'}, {'value': '66.9', 'spread': '16.6', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'Age is not available for 8 ITD, 8 Sham, 11 Analyze Early, and 18 Analyze Later subjects.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '609', 'groupId': 'BG000'}, {'value': '673', 'groupId': 'BG001'}, {'value': '605', 'groupId': 'BG002'}, {'value': '615', 'groupId': 'BG003'}, {'value': '578', 'groupId': 'BG004'}, {'value': '486', 'groupId': 'BG005'}, {'value': '313', 'groupId': 'BG006'}, {'value': '303', 'groupId': 'BG007'}, {'value': '4182', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '1208', 'groupId': 'BG000'}, {'value': '1188', 'groupId': 'BG001'}, {'value': '1016', 'groupId': 'BG002'}, {'value': '1016', 'groupId': 'BG003'}, {'value': '1055', 'groupId': 'BG004'}, {'value': '893', 'groupId': 'BG005'}, {'value': '616', 'groupId': 'BG006'}, {'value': '548', 'groupId': 'BG007'}, {'value': '7540', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender missing for one ITD and one analyze earlier subject.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '733', 'groupId': 'BG000'}, {'value': '764', 'groupId': 'BG001'}, {'value': '411', 'groupId': 'BG002'}, {'value': '691', 'groupId': 'BG003'}, {'value': '698', 'groupId': 'BG004'}, {'value': '400', 'groupId': 'BG005'}, {'value': '534', 'groupId': 'BG006'}, {'value': '489', 'groupId': 'BG007'}, {'value': '4720', 'groupId': 'BG008'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1084', 'groupId': 'BG000'}, {'value': '1097', 'groupId': 'BG001'}, {'value': '1210', 'groupId': 'BG002'}, {'value': '940', 'groupId': 'BG003'}, {'value': '935', 'groupId': 'BG004'}, {'value': '979', 'groupId': 'BG005'}, {'value': '395', 'groupId': 'BG006'}, {'value': '362', 'groupId': 'BG007'}, {'value': '7002', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11738}}, 'statusModule': {'whyStopped': 'Terminated because preliminary data suggested no difference in the strategies.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2006-10-30', 'resultsFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2006-10-30', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-03-23', 'studyFirstPostDateStruct': {'date': '2006-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).', 'timeFrame': 'Hospital discharge or death prior to discharge', 'description': 'The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.'}], 'secondaryOutcomes': [{'measure': 'Survival to Hospital Discharge', 'timeFrame': 'Survival to hospital discharge or death before discharge'}, {'measure': 'Modified Rankin Score at 6 Months After Hospital Discharge', 'timeFrame': '6 months post hospital discharge', 'description': 'The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death).'}, {'measure': 'Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months', 'timeFrame': '6 months post hospital discharge', 'description': 'The adult lifestyle and function interview (ALFI) version of the mini-mental status exam (MMSE) measures neurological status. The ALFI-MMSE has 23 items. It is scored from 0 to 22, with lower scores interpreted as being worse.'}, {'measure': 'Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months', 'timeFrame': '6 months post hospital discharge', 'description': 'The Health Utilities Index Mark 3 system was used to evaluate generic health related quality of life (HRQL). The interview-administered version of HUI3 requires completion of a maximum of 39 questions. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiac arrest', 'cardiopulmonary resuscitation'], 'conditions': ['Heart Arrest']}, 'referencesModule': {'references': [{'pmid': '21879897', 'type': 'BACKGROUND', 'citation': 'Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G; Resuscitation Outcomes Consortium (ROC) Investigators. A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):798-806. doi: 10.1056/NEJMoa1010821.'}, {'pmid': '21879896', 'type': 'RESULT', 'citation': 'Stiell IG, Nichol G, Leroux BG, Rea TD, Ornato JP, Powell J, Christenson J, Callaway CW, Kudenchuk PJ, Aufderheide TP, Idris AH, Daya MR, Wang HE, Morrison LJ, Davis D, Andrusiek D, Stephens S, Cheskes S, Schmicker RH, Fowler R, Vaillancourt C, Hostler D, Zive D, Pirrallo RG, Vilke GM, Sopko G, Weisfeldt M; ROC Investigators. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):787-97. doi: 10.1056/NEJMoa1010076.'}, {'pmid': '29310869', 'type': 'DERIVED', 'citation': 'Kawano T, Grunau B, Scheuermeyer FX, Gibo K, Fordyce CB, Lin S, Stenstrom R, Schlamp R, Jenneson S, Christenson J. Intraosseous Vascular Access Is Associated With Lower Survival and Neurologic Recovery Among Patients With Out-of-Hospital Cardiac Arrest. Ann Emerg Med. 2018 May;71(5):588-596. doi: 10.1016/j.annemergmed.2017.11.015. Epub 2018 Jan 6.'}, {'pmid': '29055890', 'type': 'DERIVED', 'citation': 'Ho ML, Gatien M, Vaillancourt C, Whitham V, Stiell IG. Utility of prehospital electrocardiogram characteristics as prognostic markers in out-of-hospital pulseless electrical activity arrests. Emerg Med J. 2018 Feb;35(2):89-95. doi: 10.1136/emermed-2017-206878. Epub 2017 Oct 21.'}, {'pmid': '27760796', 'type': 'DERIVED', 'citation': 'Reynolds JC, Grunau BE, Rittenberger JC, Sawyer KN, Kurz MC, Callaway CW. Association Between Duration of Resuscitation and Favorable Outcome After Out-of-Hospital Cardiac Arrest: Implications for Prolonging or Terminating Resuscitation. Circulation. 2016 Dec 20;134(25):2084-2094. doi: 10.1161/CIRCULATIONAHA.116.023309. Epub 2016 Oct 19.'}, {'pmid': '27554946', 'type': 'DERIVED', 'citation': 'Zheng R, Luo S, Liao J, Liu Z, Xu J, Zhan H, Liao X, Xiong Y, Idris A. Conversion to shockable rhythms is associated with better outcomes in out-of-hospital cardiac arrest patients with initial asystole but not in those with pulseless electrical activity. Resuscitation. 2016 Oct;107:88-93. doi: 10.1016/j.resuscitation.2016.08.008. Epub 2016 Aug 21.'}, {'pmid': '25565457', 'type': 'DERIVED', 'citation': 'Idris AH, Guffey D, Pepe PE, Brown SP, Brooks SC, Callaway CW, Christenson J, Davis DP, Daya MR, Gray R, Kudenchuk PJ, Larsen J, Lin S, Menegazzi JJ, Sheehan K, Sopko G, Stiell I, Nichol G, Aufderheide TP; Resuscitation Outcomes Consortium Investigators. Chest compression rates and survival following out-of-hospital cardiac arrest. Crit Care Med. 2015 Apr;43(4):840-8. doi: 10.1097/CCM.0000000000000824.'}, {'pmid': '25252721', 'type': 'DERIVED', 'citation': 'Stiell IG, Brown SP, Nichol G, Cheskes S, Vaillancourt C, Callaway CW, Morrison LJ, Christenson J, Aufderheide TP, Davis DP, Free C, Hostler D, Stouffer JA, Idris AH; Resuscitation Outcomes Consortium Investigators. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation. 2014 Nov 25;130(22):1962-70. doi: 10.1161/CIRCULATIONAHA.114.008671. Epub 2014 Sep 24.'}], 'seeAlsoLinks': [{'url': 'http://uwctc.org/', 'label': 'Click here for more information about the ROC PRIMED Trial'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.', 'detailedDescription': 'The first treatment involves using a device called the Impedance Threshold Device (ITD). The ITD is a small hard plastic device about the size of a fist that is attached to the face mask or airway tube used during CPR (cardiopulmonary resuscitation). The ITD provides increased blood flow back to the heart during chest compressions until the heart starts beating on its own again.\n\nThe other treatment involves the amount of CPR given before the emergency medical services (EMS) providers first look at the heart rhythm to determine if a shock is needed. A person would receive either about 30 seconds of chest compressions or about 3 minutes of compressions before checking the heart rhythm. Giving some compressions before checking the heart rhythm increases the blood being circulated to the body. Researchers do not know how many compressions before the rhythm check are necessary to save more lives.\n\nDepending on the circumstances of the cardiac arrest a person may receive only one of these treatments or both of these treatments. The purpose of the research study is to determine if more people live when either the real ITD is used or if additional CPR is given before looking at the heart rhythm the first time. This study is being conducted in 9 different areas throughout the United States and Canada by the Resuscitation Outcomes Consortium (ROC). About 15,000 patients will be enrolled in this research study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All persons of local age of consent or older who suffer non-traumatic cardiopulmonary arrest outside of the hospital in the study communities with defibrillation and/or delivery of chest compressions provided by emergency medical service (EMS) providers dispatched to the scene and do not meet any of the exclusion criteria.\n\nExclusion Criteria:\n\nCommon:\n\n* Do not attempt resuscitation (DNAR) orders\n* Blunt, penetrating, or burn-related injury\n* Patients with exsanguinations\n* Known prisoners\n* Known pregnancy\n* Non-ROC EMS agency/provider\n\nFor Analyzing Late versus Early\n\n* EMS-witnessed arrests\n* Non-EMS rhythm analysis (AED placed by police or lay responder is an exclusion but CPR by lay or other non-EMS responders is not)\n\nFor ITD:\n\n* Tracheostomy present\n* CPR performed with the mechanical compression "Autopulse" device.'}, 'identificationModule': {'nctId': 'NCT00394706', 'briefTitle': 'Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis', 'orgStudyIdInfo': {'id': '29919'}, 'secondaryIdInfos': [{'id': 'HL077863'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Use of Impedance Threshold Device (ITD)', 'interventionNames': ['Device: Impedance Threshold Device (ITD)']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'Sham ITD', 'interventionNames': ['Device: Sham ITD']}, {'type': 'OTHER', 'label': '3', 'description': 'Analyze early. Upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.', 'interventionNames': ['Other: Analyze early']}, {'type': 'OTHER', 'label': '4', 'description': 'Analyze late. Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.', 'interventionNames': ['Other: Analyze later']}], 'interventions': [{'name': 'Impedance Threshold Device (ITD)', 'type': 'DEVICE', 'description': 'Use of Impedance Threshold Device (ITD)', 'armGroupLabels': ['1']}, {'name': 'Sham ITD', 'type': 'DEVICE', 'description': 'Sham ITD', 'armGroupLabels': ['2']}, {'name': 'Analyze early', 'type': 'OTHER', 'description': 'Upon EMS arrival at the scene of a non-traumatic cardiac arrest, an assessment of the cardiac rhythm is done to determine whether a defibrillatory shock is required.', 'armGroupLabels': ['3']}, {'name': 'Analyze later', 'type': 'OTHER', 'description': 'Upon EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is given prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Resuscitation Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD-San Diego Resuscitation Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Pittsburgh Resuscitation Network, University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle-King County Center for Resuscitation Research, University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Milwaukee Resuscitation Network, Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'K1Y4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Myron L Weisfeldt, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Defence Research and Development Canada', 'class': 'INDUSTRY'}, {'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}, {'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Susanne May', 'investigatorAffiliation': 'University of Washington'}}}}