Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT03108118
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Injury and Dysfunction During Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm dysfunction', 'timeFrame': '7 days', 'description': 'Diaphragm dysfunction will be defined as maximal transdiaphragmatic pressure \\< 30 cm H2O and/or maximal diaphragm thickening fraction \\< 20% at study completion'}], 'secondaryOutcomes': [{'measure': 'Diaphragm thickness', 'timeFrame': '7 days'}, {'measure': 'Diaphragm neuromuscular coupling', 'timeFrame': '7 days'}, {'measure': 'Duration of inactivity (hours)', 'timeFrame': '7 days'}, {'measure': 'Patient-ventilator asynchrony rate', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diaphragm dysfunction', 'Acute respiratory failure', 'Weaning'], 'conditions': ['Respiratory Insufficiency', 'Diaphragm Injury', 'Mechanical Ventilation Complication']}, 'referencesModule': {'references': [{'pmid': '20813887', 'type': 'BACKGROUND', 'citation': 'Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.'}, {'pmid': '18367735', 'type': 'BACKGROUND', 'citation': 'Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.'}, {'pmid': '26167730', 'type': 'RESULT', 'citation': 'Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.'}, {'pmid': '38566126', 'type': 'DERIVED', 'citation': 'Coiffard B, Dianti J, Telias I, Brochard LJ, Slutsky AS, Beck J, Sinderby C, Ferguson ND, Goligher EC. Dyssynchronous diaphragm contractions impair diaphragm function in mechanically ventilated patients. Crit Care. 2024 Apr 2;28(1):107. doi: 10.1186/s13054-024-04894-3.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the relationship between diaphragm activity during mechanical ventilation and the development of ventilator-induced diaphragm dysfunction (VIDD). Diaphragm structure, activity, and function are monitored longitudinally over the first 7 days of mechanical ventilation.', 'detailedDescription': 'Multiple factors are responsible for injury to the diaphragm during mechanical ventilation and critical illness. Suppression of respiratory drive and respiratory muscle activity can contribute to diaphragm dysfunction and increase the risk of prolonged mechanical ventilation.\n\nThe objective of this study is to determine whether diaphragm inactivity or injurious loading of hte diaphragm during mechanical ventilation leads to the development of diaphragm weakness. To address this question, we are monitoring the diaphragm longitudinally over the first week of mechanical ventilation.\n\nDiaphragm activity is monitored by measurements of transdiaphragmatic pressure and diaphragm electrical activity. Diaphragm function is assessed by maximal transdiaphragmatic pressure generation and by measurements of diaphragm neuromuscular coupling. Diaphragm structure is assessed by daily ultrasound imaging.\n\nStudy measurments commence at enrolment (within 36 hours of intubation) and continue for the first 7 days of the study (or until extubation or death, if earlier).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients who are receiving invasive mechanical ventilation for less than 36 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18) with acute respiratory failure receiving invasive mechanical ventilation for less than 36 hours diagnosed with any of the following conditions: acute severe brain injury; moderate or severe ARDS; septic shock; pneumonia\n\nExclusion Criteria:\n\n* Predicted probability of remaining alive and on the ventilator on ICU day 7 is less than 50%\n* Liberation from mechanical ventilation is expected/planned within 24 hours\n* High cervical spine injury (C5 or higher)\n* Receiving mechanical ventilation for neuromuscular disease\n* Acute exacerbation of an obstructive lung disease\n* Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe\n* Esophageal, gastric or duodenal surgical procedures within the last 6 months\n* Received mechanical ventilation for \\> 48 hours in the preceding 6 months'}, 'identificationModule': {'nctId': 'NCT03108118', 'acronym': 'MYOTRAUMA', 'briefTitle': 'Diaphragm Injury and Dysfunction During Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Diaphragm Injury and Dysfunction During Mechanical Ventilation', 'orgStudyIdInfo': {'id': '12-5582-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute respiratory failure', 'description': 'We are enrolling patients who are intubated because of acute respiratory distress syndrome, pneumonia, septic shock, or severe acute brain injury (GCS ≤ 8 prior to intubation). This population is targeted for study because they are at relatively high risk of requiring prolonged mechanical ventilation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Ewan C Goligher, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Intensivist', 'investigatorFullName': 'Ewan Goligher', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}