Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation

NCT ID: NCT05825703

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2023-05-30

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.

Conditions

Pediatric Liver Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

PPMV

GROUP OF PATIENT POPULATION WHO HAD PROLONGED POST-OPERATIVE MECHANICAL VENTILATION

No interventions assigned to this group

NON PPMV

GROUP OF PATIENT POPULATION WHO DID NOT HAVE PROLONGED POST-OPERATIVE MECHANICAL VENTILATION

No interventions assigned to this group

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ILBS

New Delhi, , India

Countries

India

Facility Contacts

MANOJ K P, MD

Role: primary

manojmannu972@gmail.com

9008144931

UDIT DHINGRA, MD

Role: backup

uddh1989@gmail.com

8861987684

Other Identifiers

ILBS/DOA/2022/23757/978

Identifier Type: -

Identifier Source: org_study_id