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Clinical Trials/NCT05825703
NCT05825703
Not yet recruiting
Not Applicable

Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation in Pediatric Liver Transplant Recipients: A Retrospective Study

Institute of Liver and Biliary Sciences, India1 site in 1 country60 target enrollmentApril 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Liver Transplantation
Sponsor
Institute of Liver and Biliary Sciences, India
Enrollment
60
Locations
1
Primary Endpoint
Number of participants with post-operative mechanical ventilation
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

The primary goal of the study is to identify incidence and risk factors for PPMV in pediatric patients undergoing liver transplantation.

Detailed Description

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. Although 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. To our knowledge, factors associated with PPMV following pediatric liver transplantation have not been comprehensively characterized.

Registry
clinicaltrials.gov
Start Date
April 30, 2023
End Date
May 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All Pediatric patients aged \<17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.

Exclusion Criteria

  • Patients who required mechanical ventilation during the 48 hr preceding surgery.
  • Older than 18 yr at the time of transplantation
  • Acute liver failure
  • Acute on chronic liver failure

Outcomes

Primary Outcomes

Number of participants with post-operative mechanical ventilation

Time Frame: 24 hours

To identify risk factors for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.

Secondary Outcomes

  • Incidence of PPMV(24 hours)
  • total duration of icu stay and length of stay in hospital.(From the day of admission to discharge or death, whichever comes first,upto 12 weeks)
  • incidence of tracheostomy/re-intubation(28 days post-op)
  • incidence of 28 day mortality(28 days post-op)

Study Sites (1)

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