Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:02 PM
Study NCT ID:
NCT03480828
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2018-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2018-03-22', 'studyFirstSubmitQcDate': '2018-03-22', 'lastUpdatePostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'extubation success', 'timeFrame': '48 hours after extubation', 'description': 'comparaison between DE and DTF values in successfully extubated patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Accuracy of DE and DTF in Prediction of Extubation Success']}, 'descriptionModule': {'briefSummary': 'This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation.', 'detailedDescription': 'This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation. The investigators compared the median values of DE and DTF in the group of successfully extubated patients and the group of patients who needed reintubation.\n\nOur study compared the utility of DTF and DE to predict extubation success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients who were mechanically ventilated for more than 48 hours and meeting all extubation criteria without a history of neuromuscular disease or severe chronic respiratory failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who were mechanically ventilated for more than 48h and meeting all criteria for extubation\n* patients without history of neuromuscular disease, or severe chronic respiratory failure\n\nExclusion Criteria:\n\n* patients who needed reintubation for upper airway obstruction or neurological or hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT03480828', 'briefTitle': 'Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mongi Slim Hospital'}, 'officialTitle': 'Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': 'rea1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'comparaison between DE and DTF in prediction of extubation success', 'type': 'DIAGNOSTIC_TEST', 'description': 'diaphragm ultrasound and measurement of DE and DTF in patients meeting all extubation criteria during spontaneous breathing trial'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2046', 'city': 'La Marsa', 'state': 'Tunis Governorate', 'country': 'Tunisia', 'facility': 'Mongi Slim Hospital', 'geoPoint': {'lat': 36.87818, 'lon': 10.32466}}], 'overallOfficials': [{'name': 'Mhamed Sami Mebazaa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mongi Slim Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mongi Slim Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor head of the anesthesia and intensive care department', 'investigatorFullName': 'Mhamed Sami Mebazaa', 'investigatorAffiliation': 'Mongi Slim Hospital'}}}}