Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-31 @ 2:52 AM
Study NCT ID:
NCT04339257
Status:
UNKNOWN
Last Update Posted:
2020-05-05
First Post:
2020-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-hospital Post ROSC Care: Are we Achieving Our Targets?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}, {'id': 'D000080942', 'term': 'Post-Cardiac Arrest Syndrome'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 175}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-01', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-04-05', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of OHCA patients with a prehospital ROSC who arrive in hospital with either a deranged physiology or with complications from OHCA EMS personnel was unable to deal with', 'timeFrame': 'From pre-hospital ROSC to arrival at ED, approximately 1-2 hours', 'description': 'Any of the below 5 minutes or more after ROSC is obtained:\n\n* -Airway intervention (SGA or ETT) not performed (when deemed necessary)\n* Actively Vomiting in absence of ETT after ROSC B: -Hypoxia: -SaO2 \\<94% on at least two consecutive readings\n* Hypercarbia: -ETCO2\\>5.5 kPa on at least two consecutive readings\\*\\* C: -Low cardiac output: -Re-arrest during transport to hospital\n* ETCO2\\<3.0 on two consecutive readings\n* MAP\\<65mmHg on two consecutive readings\n* SBP\\<100 mmHg on two consecutive readings upon arrival in ED D: -Hypoxic agitation upon arrival in ED or uncontrolled prehospital hypoxic agitation despite benzodiazepine administration or when benzodiazepines contraindicated)\n* Seizures during transport E: -Hyperthermia'}], 'secondaryOutcomes': [{'measure': 'Duration of period with deranged physiology, measured from moment of first occurrence until resolved or until arrival in hospital.', 'timeFrame': 'From pre-hospital ROSC to arrival at ED, approximately 1-2 hours', 'description': 'Any of the following measured in minutes:\n\n* -Airway intervention (SGA or ETT) not performed (when deemed necessary)\n* Actively Vomiting in absence of ETT after ROSC B: -Hypoxia: -SaO2 \\<94% on at least two consecutive readings\n* Hypercarbia: -ETCO2\\>5.5 kPa on at least two consecutive readings\\*\\* C: -Low cardiac output: -Re-arrest during transport to hospital\n* ETCO2\\<3.0 on two consecutive readings\n* MAP\\<65mmHg on two consecutive readings\n* SBP\\<100 mmHg on two consecutive readings upon arrival in ED D: -Hypoxic agitation upon arrival in ED or uncontrolled prehospital hypoxic agitation despite benzodiazepine administration or when benzodiazepines contraindicated)\n* Seizures during transport E: -Hyperthermia'}, {'measure': 'Patient- and resuscitation factors related to deranged physiology and/or complications in the post arrest phase', 'timeFrame': 'From pre-hospital ROSC to arrival at ED, approximately 1-2 hours'}, {'measure': 'Opinion of EMS providers weather or not they felt they were able to provide optimal post arrest care', 'timeFrame': 'From pre-hospital ROSC to arrival at emergency department, approximately 1-2 hours', 'description': 'Measured by a survey, filled out by EMS crew at arrival at ED'}, {'measure': 'Comparison of primary outcome of secondary outcomes between post ROSC patients attended by EMS only vs EMS and HEMS', 'timeFrame': 'From pre-hospital ROSC to arrival at emergency department, approximately 1-2 hours'}, {'measure': 'Frequency distribution of airway interventions (SGA or ETT) not performed (when deemed necessary)', 'timeFrame': 'From pre-hospital ROSC to arrival at emergency department, approximately 1-2 hours', 'description': '-Airway intervention (SGA or ETT) not performed (when deemed necessary) in ED. NB NOT change of SGA for ETT when SGA is functioning well'}, {'measure': 'Frequency distribution of actively vomiting in absence of ETT after ROSC in prehospital setting', 'timeFrame': 'From pre-hospital ROSC to arrival at ED, approximately 1 to 2 hours'}, {'measure': 'Frequency distribution of the presence of hypoxia', 'timeFrame': 'From pre-hospital ROSC to arrival at ED, approximately 1 to 2 hours', 'description': 'SaO2 \\<94% on at least two consecutive readings'}, {'measure': 'Frequency distribution of low cardiac output', 'timeFrame': 'From pre-hospital ROSC to ICU (or CCU) admission, up to about 1 hours', 'description': 'Presence of one of the following:\n\n* Re-arrest during transport to hospital\n* ETCO2\\<3.0 on two consecutive readings\n* MAP\\<65mmHg on two consecutive readings 12\n* SBP\\<100 mmHg on two consecutive readings'}, {'measure': 'Frequency distribution of hypoxic agitation upon arrival in ED or uncontrolled prehospital hypoxic agitation despite benzodiazepine administration or when benzodiazepines contraindicated)', 'timeFrame': 'From pre-hospital ROSC to arrival at ED, approximately 1-2 hours', 'description': 'Assessed by physician who enrolls patient'}, {'measure': 'Frequency distribution of seizures during transport', 'timeFrame': 'From pre-hospital ROSC to arrival at ED, approximately 1-2 hours'}, {'measure': 'Frequency distribution of the presence of hyperthermia', 'timeFrame': 'From pre-hospital ROSC to arrival at ED, approximately 1-2 hours', 'description': 'Defined as a temperature \\>37.5 celsius'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Out-Of-Hospital Cardiac Arrest', 'Post Cardiac Arrest Syndrome', 'Emergency Medical Services']}, 'descriptionModule': {'briefSummary': "Rational: Out of hospital cardiac arrest is a devastating event with a high mortality. Survival rates have increased over the last years, with the availability of AED's and public BLS. Previous studies have shown that deranged physiology after return of spontaneous circulation (ROSC) is associated with a worse neurological outcome. Good quality post-arrest care is therefore of utmost importance.\n\nObjective: To determine how often prehospital crews (with their given skills set) encounter problems meeting optimal post-ROSC targets in patients suffering from OHCA, and to investigate if this can be predicted based on patient-, provider- or treatment factors.\n\nStudy design: Prospective cohort study of all patients attended by the EMS services with an OHCA who regain ROSC and are transported to a single university hospital, in order to identify those patients with a ROSC after a non-traumatic OHCA who had deranged physiology and/or complications from OHCA EMS personnel was unable to prevent/deal with in the prehospital environment.\n\nStudy population: Patients, \\>18 years, transported by the EMS services to the ED of the University Hospital Groningen (UMCG) with a ROSC after OHCA in a 1 year period\n\nMain study parameters/endpoints: Primary endpoint of our study is the percentage of OHCA patients with a prehospital ROSC who arrive in hospital with either a deranged physiology or with complications from OHCA EMS personnel was unable to deal with."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (\\>18 years) patients with ROSC after OHCA transported to University Hospital Groningen by the EMS services.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Non-traumatic OHCA (as confirmed in notes of ambulance crew) with ROSC obtained before transport to hospital\n* Age \\> 18\n\nExclusion criteria:\n\n* Traumatic cause of arrest (NB asphyxia due to hanging, electrocutions and drowning are not considered as traumatic arrests in this study, as normal ALS algorithms (special circumstances) are followed for these patients\n* No ROSC before leaving OHCA\n* Age \\<18\n* Informed opt out of medical research of patient'}, 'identificationModule': {'nctId': 'NCT04339257', 'acronym': 'POP-ROC', 'briefTitle': 'Pre-hospital Post ROSC Care: Are we Achieving Our Targets?', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Which Patients With a ROSC After OHCA Would Potentially Benefit From Physician Driven Post Cardiac Arrest Care?', 'orgStudyIdInfo': {'id': '201900756'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fabian Lucassen, drs', 'role': 'CONTACT', 'email': 'f.g.lucassen@umcg.nl', 'phone': '0031-503614359'}, {'name': 'Ewoud ter Avest, dr', 'role': 'CONTACT', 'email': 'e.ter.avest@umcg.nl', 'phone': '0031-503614359'}], 'overallOfficials': [{'name': 'Ewoud ter Avest, dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fabian Lucassen', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}