Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric 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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110070
    • ILBS
    • Contact: MANOJ K P, MD; Phone Number: 9008144931; Email: manojmannu972@gmail.com
    • Contact: UDIT DHINGRA, MD; Phone Number: 8861987684; Email: uddh1989@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PPMV; GROUP OF PATIENT POPULATION WHO HAD PROLONGED POST-OPERATIVE MECHANICAL VENTILATION
NON PPMV; GROUP OF PATIENT POPULATION WHO DID NOT HAVE PROLONGED POST-OPERATIVE MECHANICAL VENTILATION

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Publications and helpful links

Helpful Links

• Factors Associated with Postoperative Prolonged Mechanical Ventilation in Pediatric Liver Transplant Recipients

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2023
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: April 1, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pediatric Liver Transplantation; Post-operative Mechanical Ventilation
• Other Study ID Numbers: ILBS/DOA/2022/23757/978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No