Clinical trial NCT05825703: Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation
Official title: Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation in Pediatric Liver Transplant Recipients: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Liver Transplantation
Keywords: Pediatric Liver Transplantation
Post-operative Mechanical Ventilation
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 60
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number of participants with post-operative mechanical ventilation
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of PPMV
timeFrame: 24 hours
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
measure: incidence of tracheostomy/re-intubation
timeFrame: 28 days post-op
measure: incidence of 28 day mortality
timeFrame: 28 days post-op
Other outcomes:
Locations:
city: New Delhi
country: India
facility: ILBS
Study officials:
References: