Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation

Pediatric Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05825703
• Other study ID #: ILBS/DOA/2022/23757/978
• Status: Not yet recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 30, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Liver Transplantation

Locations

Country	Name	City	State
India	ILBS	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of PPMV	To identify risk INCIDENCE for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.	24 hours
Secondary	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
Secondary	incidence of tracheostomy/re-intubation	To identify incidence of tracheostomy/re-intubation of prolonged post-operative mechanical ventilation (PPMV).	28 days post-op
Secondary	incidence of 28 day mortality	To identify incidence of 28 day mortality prolonged post-operative mechanical ventilation (PPMV) group.	28 days post-op

External Links

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