Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-28 @ 5:35 AM
Study NCT ID:
NCT05825703
Status:
UNKNOWN
Last Update Posted:
2023-04-24
First Post:
2023-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation
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': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2023-04-01', 'studyFirstSubmitQcDate': '2023-04-20', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with post-operative mechanical ventilation', 'timeFrame': '24 hours', 'description': 'To identify risk factors for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.'}], 'secondaryOutcomes': [{'measure': 'Incidence of PPMV', 'timeFrame': '24 hours', 'description': 'To identify risk INCIDENCE for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.'}, {'measure': 'total duration of icu stay and length of stay in hospital.', 'timeFrame': 'From the day of admission to discharge or death, whichever comes first,upto 12 weeks', 'description': 'To identify effect of prolonged post-operative mechanical ventilation (PPMV) on total duration of icu stay and length of stay in hospital.'}, {'measure': 'incidence of tracheostomy/re-intubation', 'timeFrame': '28 days post-op', 'description': 'To identify incidence of tracheostomy/re-intubation of prolonged post-operative mechanical ventilation (PPMV).'}, {'measure': 'incidence of 28 day mortality', 'timeFrame': '28 days post-op', 'description': 'To identify incidence of 28 day mortality prolonged post-operative mechanical ventilation (PPMV) group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Liver Transplantation', 'Post-operative Mechanical Ventilation'], 'conditions': ['Pediatric Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'The primary goal of the study is to identify incidence and risk factors for PPMV in pediatric patients undergoing liver transplantation.', 'detailedDescription': 'The vast majority of children undergoing orthotopic liver transplantation (OLT) are maintained on mechanical ventilation (MV) in the immediate postoperative period. Reasons for this practice include concerns about graft function, postoperative respiratory depression from opioids, preexisting malnutrition, and organ-recipient size mismatch as well as poor cooperation of young children with postoperative instructions. With current improvements in the perioperative care, there is increasing drive towards early extubation in both adults and children.\n\nAlthough many children require only a few days of MV following OLT, some require a more prolonged course. In general, prolonged postoperative mechanical ventilation (PPMV) in intensive care unit (ICU) patients is marker of severe adverse events and is associated with higher morbidity and mortality as well as extraordinary resource utilization. Patients requiring PPMV have survived the acute phase of surgery but spend an increased amount of time in the ICU, consume about 50% of all intensive care unit (ICU) resources and are more likely to die. Consequently, investigating the incidence and factors predisposing to PPMV following liver transplant is an important area of research with potential to reduce cost of care and improve long-term outcome of patients.\n\nTo our knowledge, factors associated with PPMV following pediatric liver transplantation have not been comprehensively characterized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Pediatric patients aged \\<17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Pediatric patients aged \\<17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.\n\nExclusion Criteria:\n\n* Patients who required mechanical ventilation during the 48 hr preceding surgery.\n* Older than 18 yr at the time of transplantation\n* Acute liver failure\n* Acute on chronic liver failure'}, 'identificationModule': {'nctId': 'NCT05825703', 'briefTitle': 'Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation in Pediatric Liver Transplant Recipients: A Retrospective Study', 'orgStudyIdInfo': {'id': 'ILBS/DOA/2022/23757/978'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PPMV', 'description': 'GROUP OF PATIENT POPULATION WHO HAD PROLONGED POST-OPERATIVE MECHANICAL VENTILATION'}, {'label': 'NON PPMV', 'description': 'GROUP OF PATIENT POPULATION WHO DID NOT HAVE PROLONGED POST-OPERATIVE MECHANICAL VENTILATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'country': 'India', 'contacts': [{'name': 'MANOJ K P, MD', 'role': 'CONTACT', 'email': 'manojmannu972@gmail.com', 'phone': '9008144931'}, {'name': 'UDIT DHINGRA, MD', 'role': 'CONTACT', 'email': 'uddh1989@gmail.com', 'phone': '8861987684'}], 'facility': 'ILBS', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}