Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation

Not yet recruiting

• Conditions: Pediatric Liver Transplantation

• Registration Number: NCT05825703
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2023-04-01
• Study First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24
• Study Start: 2023-04-30
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with post-operative mechanical ventilation	24 hours	To identify risk factors for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.

Secondary Outcome Measures

Name	Time	Method
Incidence of PPMV	24 hours	To identify risk INCIDENCE for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.
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	To identify effect of prolonged post-operative mechanical ventilation (PPMV) on total duration of icu stay and length of stay in hospital.
incidence of tracheostomy/re-intubation	28 days post-op	To identify incidence of tracheostomy/re-intubation of prolonged post-operative mechanical ventilation (PPMV).
incidence of 28 day mortality	28 days post-op	To identify incidence of 28 day mortality prolonged post-operative mechanical ventilation (PPMV) group.

Trial Locations

Locations (1)

ILBS; 🇮🇳 New Delhi, India