Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01151618
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2010-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bob.romano@philips.com', 'phone': '724-387-7781', 'title': 'Bob Romano, Biomedical Engineer', 'organization': 'Philips Respironics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Over course of the study which was 3 months in duration.', 'eventGroups': [{'id': 'EG000', 'title': 'Therapy Arm', 'description': 'Non Invasive Ventilation using forced oscillation technique (FOT)', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chronic Obstructive Pulmonary Disease Exacerbation', 'notes': '2 participants had COPD exacerbations after consent but prior to study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Detection of Expiratory Flow Limitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapy Arm', 'description': 'Non Invasive Ventilation using forced oscillation technique (FOT)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'DeltaXrs (cmH2O*s/L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.6', 'ciLowerLimit': '0', 'ciUpperLimit': '100', 'estimateComment': 'DeltaXrs equals average inspiratory reactance minus average expiratory reactance.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Sensitivity and Specificity of values with respect to the Mead Whittenberger method were computed as follows (FL=flow limited and NFL = Non Flow limited):\n\nSensitivity = (# of FL breaths detected by FOT / # of FL breaths detected by M\\&W) \\* 100 Specificity =(# of NFL breaths detected by FOT / # of NFL breaths detected by M\\&W) \\* 100'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'within 2 hours', 'description': 'Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm).\n\nExpiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O\\*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures).\n\nTwo measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL.', 'unitOfMeasure': 'cmH2O*s/L', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that completed the protocol were analyzed.'}, {'type': 'PRIMARY', 'title': 'Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapy Arm', 'description': 'Non Invasive Ventilation using forced oscillation technique (FOT)'}], 'classes': [{'title': 'Flow limited', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Not Flow Limited', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that completed the protocol were analyzed.'}, {'type': 'PRIMARY', 'title': 'Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapy Arm', 'description': 'Non Invasive Ventilation using forced oscillation technique (FOT)'}], 'classes': [{'title': 'Flow limited', 'categories': [{'measurements': [{'value': '534', 'groupId': 'OG000'}]}]}, {'title': 'Not Flow Limited', 'categories': [{'measurements': [{'value': '567', 'groupId': 'OG000'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '1396', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': "Number of breaths are cumulative across all participants were found to be flow limited, not-flow limited or indeterminate as determined by the Mead and Wittenberger (M-W) technique of esophageal pressure. Each participant's individual breaths was imported into Matlab software program that displayed the flow vs transpleural pressure and breaths were individually analyzed according to the Mead Wittenberger technique.", 'unitOfMeasure': 'breaths', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that completed the protocol were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Therapy Arm', 'description': 'Non Invasive Ventilation using forced oscillation technique (FOT)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Participants were recruited and screened with spirometry and determination of expiratory flow limitation prior to being enrolled into the study.', 'preAssignmentDetails': "22 patient were recruited in June of 2010.\n\n* 13 patients studied\n* (7 didn't tolerate balloon; 2 had an exacerbation )"}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Therapy Arm', 'description': 'Non Invasive Ventilation using forced oscillation technique (FOT)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '7.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-15', 'studyFirstSubmitDate': '2010-06-21', 'resultsFirstSubmitDate': '2011-02-24', 'studyFirstSubmitQcDate': '2010-06-25', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-15', 'studyFirstPostDateStruct': {'date': '2010-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Expiratory Flow Limitation', 'timeFrame': 'within 2 hours', 'description': 'Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm).\n\nExpiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O\\*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures).\n\nTwo measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL.'}, {'measure': 'Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator', 'timeFrame': '2 hours', 'description': 'Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.'}, {'measure': 'Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique', 'timeFrame': '2 hours', 'description': "Number of breaths are cumulative across all participants were found to be flow limited, not-flow limited or indeterminate as determined by the Mead and Wittenberger (M-W) technique of esophageal pressure. Each participant's individual breaths was imported into Matlab software program that displayed the flow vs transpleural pressure and breaths were individually analyzed according to the Mead Wittenberger technique."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'To validate the capability of the Respironics Synchrony ventilator to properly detect Expiratory Flow Limitation (EFL) as compared to the gold standard method of detecting EFL via the Mead and Wittenberger technique.', 'detailedDescription': 'Positive end expiratory pressure (PEEP) is used in COPD patients to counteract the intrinsic PEEP (PEEPi), which represents the end expiratory recoil pressure of the total respiratory system due to the presence of dynamic hyperinflation (DH).\n\nDH commonly occurs in COPD, where the presence of expiratory flow-limitation (EFL) requires the patient to breath at higher lung volumes to produce the necessary after appropriate leak correction, showed a sensitivity and specificity in detecting EFL expiratory flow. To be effective, the PEEP level applied to the patient should be equal to PEEPi.\n\nThe continuous monitoring of EFL could be a useful tool to select the minimum PEEP level required to abolish it.\n\nEFL can be detected using the forced oscillation technique (FOT) by an index which quantifies, for each breath, the within-breath variations of respiratory reactance (delta Xrs) at 5Hz.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Age \\< 80 years\n2. Moderate - Severe COPD diagnosed by spirometry (according to the GOLD criteria - Global Initiative for Chronic Obstructive Lung Disease criteria)\n3. Free from any exacerbation in the 6 weeks preceding the study\n\nExclusion Criteria\n\n1. Any co-existing cardio-pulmonary conditions which may result in a picture of ventilatory failure such as congestive cardiac failure, chest wall or neuromuscular disease, bronchopneumonia, pulmonary fibrosis, bronchiectasis, cystic fibrosis or obesity-hypoventilation syndrome\n2. Clinically unstable; exacerbation within the preceding 6 weeks\n3. The presence of pulmonary or extra-pulmonary neoplasia that is still active\n4. The presence of a bleeding diathesis\n5. Unstable coronary artery disease\n6. Presence of tuberculosis, current infection or potentially infectious pathogen\n7. Inability to provide informed consent to the study'}, 'identificationModule': {'nctId': 'NCT01151618', 'briefTitle': 'Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Respironics'}, 'officialTitle': 'Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation in Patients With Stable Chronic Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'HRC-1018-FOTVal-SS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Respironics Synchrony ventilator (Non Invasive Ventilation)', 'description': 'Non Invasive Ventilation using forced oscillation technique (FOT)', 'interventionNames': ['Device: Respironics Synchrony ventilator (Non Invasive Ventilation)']}], 'interventions': [{'name': 'Respironics Synchrony ventilator (Non Invasive Ventilation)', 'type': 'DEVICE', 'description': 'Non Invasive Ventilation using forced oscillation technique (FOT)', 'armGroupLabels': ['Respironics Synchrony ventilator (Non Invasive Ventilation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L97AL', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'University Hospital Aintree', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Peter Calverley, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aintree University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Respironics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}