Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT05191433
Status:
UNKNOWN
Last Update Posted:
2022-01-13
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mechanical Ventilation on the Diaphragm in COVID-19 Intensive Care Patients. A Post-mortem Pathology Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2022-01-11', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical characteristics', 'timeFrame': 'One week post mortem', 'description': 'Evaluate if there are specific clusters in the study population and find different clinical characteristics.'}, {'measure': 'Blood test characteristics', 'timeFrame': 'One week post mortem', 'description': 'Evaluate if there are specific clusters in the study population and find different blood test characteristics.'}, {'measure': 'Pathology characteristics', 'timeFrame': 'One week post mortem', 'description': 'Evaluate if there are specific clusters in the study population and find different pathology characteristics.'}], 'secondaryOutcomes': [{'measure': 'Mechanical ventilation', 'timeFrame': 'One week post mortem', 'description': 'Verify if there are correlations between the clusters characteristics and the other variables in the study population mechanical ventilation.'}, {'measure': 'Therapy', 'timeFrame': 'One week post mortem', 'description': 'Verify if there are correlations between the clusters characteristics and therapy in the study population.'}, {'measure': 'Arterial blood gas analysis', 'timeFrame': 'One week post mortem', 'description': 'Verify if there are correlations between the clusters characteristics and arterial blood gas in the study population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaphragm Injury', 'Pathology', 'COVID-19 Acute Respiratory Distress Syndrome', 'Ventilation Therapy; Complications']}, 'referencesModule': {'references': [{'pmid': '29779594', 'type': 'BACKGROUND', 'citation': 'McCool FD, Manzoor K, Minami T. Disorders of the Diaphragm. Clin Chest Med. 2018 Jun;39(2):345-360. doi: 10.1016/j.ccm.2018.01.012.'}, {'pmid': '28887062', 'type': 'BACKGROUND', 'citation': 'Supinski GS, Morris PE, Dhar S, Callahan LA. Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5.'}, {'pmid': '28917004', 'type': 'BACKGROUND', 'citation': 'Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.'}, {'pmid': '28930478', 'type': 'BACKGROUND', 'citation': 'Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.'}, {'pmid': '25760684', 'type': 'BACKGROUND', 'citation': 'Hooijman PE, Beishuizen A, Witt CC, de Waard MC, Girbes AR, Spoelstra-de Man AM, Niessen HW, Manders E, van Hees HW, van den Brom CE, Silderhuis V, Lawlor MW, Labeit S, Stienen GJ, Hartemink KJ, Paul MA, Heunks LM, Ottenheijm CA. Diaphragm muscle fiber weakness and ubiquitin-proteasome activation in critically ill patients. Am J Respir Crit Care Med. 2015 May 15;191(10):1126-38. doi: 10.1164/rccm.201412-2214OC.'}, {'pmid': '34544735', 'type': 'BACKGROUND', 'citation': 'Shi Z, Bogaards SJP, Conijn S, Onderwater Y, Espinosa P, Bink DI, van den Berg M, van de Locht M, Bugiani M, van der Hoeven H, Boon RA, Heunks L, Ottenheijm CAC. COVID-19 is associated with distinct myopathic features in the diaphragm of critically ill patients. BMJ Open Respir Res. 2021 Sep;8(1):e001052. doi: 10.1136/bmjresp-2021-001052.'}]}, 'descriptionModule': {'briefSummary': 'The diaphragm is the fundamental muscle of the respiratory system. The diaphragmatic dysfunction is present in 60% of critical patients at hospital admission and up to 80% after prolonged mechanical ventilation and difficult weaning.\n\nRisk factors associated with diaphragm dysfunction and atrophy are sepsis, trauma, sedatives, steroids, and muscle relaxants.\n\nThe main pathology characteristics of diaphragm biopsies of mechanically ventilated patients are atrophy and a reduction in contractility, determining an impact on the clinical outcome.\n\nShi et al. found a higher section area of the diaphragm muscle fiber in biopsies of post mortem COVID-19 patients versus negative patients, independently from days of mechanical ventilation.\n\nThe hypothesis of our study is to identify different clusters of pathological presentation in post-mortem COVID-19 mechanically ventilated patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Deceased COVID-19 patients admitted to the intensive care unit and mechanically ventilated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients deceased in the intensive care unit positive to SARS-CoV-2 and mechanically ventilated\n* post-mortem examination of the diaphragm\n\nExclusion Criteria:\n\n* patients with a terminal disease and a prognosis of less than 48 hours at admission.'}, 'identificationModule': {'nctId': 'NCT05191433', 'briefTitle': 'Effects of Mechanical Ventilation on the Diaphragm in COVID-19 Intensive Care Patients. A Post-mortem Pathology Study', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria-Universitaria Integrata di Udine'}, 'officialTitle': 'Effects of Mechanical Ventilation on the Diaphragm in COVID-19 Intensive Care Patients. A Post-mortem Pathology Study.', 'orgStudyIdInfo': {'id': 'COVID DIAPHRAGM'}}, 'contactsLocationsModule': {'locations': [{'zip': '33100', 'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Vetrugno, M.D.', 'role': 'CONTACT', 'email': 'luigi.vetrugno@asuiud.sanita.fvg.it', 'phone': '+393382873386'}], 'facility': 'Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tiziana Bove', 'role': 'CONTACT'}], 'facility': 'Azienda ospedaliero universitaria Friuli Centrale, Clinica di Anestesia e Rianimazione', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'centralContacts': [{'name': 'Luigi Vetrugno, MD', 'role': 'CONTACT', 'email': 'luigi.vetrugno@asufc.sanita.fvg.it', 'phone': '+ 39 0432559509'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria-Universitaria Integrata di Udine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Anesthesia and Intensive Care', 'investigatorFullName': 'Luigi Vetrugno', 'investigatorAffiliation': 'Azienda Sanitaria-Universitaria Integrata di Udine'}}}}