Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation

Sponsor
Institute of Liver and Biliary Sciences, India (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05825703
Collaborator
(none)
60
1
30
60.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation in Pediatric Liver Transplant Recipients: A Retrospective Study
    Anticipated Study Start Date :
    Apr 30, 2023
    Anticipated Primary Completion Date :
    May 15, 2023
    Anticipated Study Completion Date :
    May 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with post-operative mechanical ventilation [24 hours]

      To identify risk factors for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.

    Secondary Outcome Measures

    1. Incidence of PPMV [24 hours]

      To identify risk INCIDENCE for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.

    2. 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]

      To identify effect of prolonged post-operative mechanical ventilation (PPMV) on total duration of icu stay and length of stay in hospital.

    3. incidence of tracheostomy/re-intubation [28 days post-op]

      To identify incidence of tracheostomy/re-intubation of prolonged post-operative mechanical ventilation (PPMV).

    4. incidence of 28 day mortality [28 days post-op]

      To identify incidence of 28 day mortality prolonged post-operative mechanical ventilation (PPMV) group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ILBS New Delhi India 110070

    Sponsors and Collaborators

    • Institute of Liver and Biliary Sciences, India

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Institute of Liver and Biliary Sciences, India
    ClinicalTrials.gov Identifier:
    NCT05825703
    Other Study ID Numbers:
    • ILBS/DOA/2022/23757/978
    First Posted:
    Apr 24, 2023
    Last Update Posted:
    Apr 24, 2023
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institute of Liver and Biliary Sciences, India

    Study Results

    No Results Posted as of Apr 24, 2023