Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05825703 |
Other study ID # |
ILBS/DOA/2022/23757/978 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 30, 2023 |
Est. completion date |
May 30, 2023 |
Study information
Verified date |
September 2022 |
Source |
Institute of Liver and Biliary Sciences, India |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The primary goal of the study is to identify incidence and risk factors for PPMV in pediatric
patients undergoing liver transplantation.
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.