Early Extubation and Postoperative Complications After Liver Transplantation

June 7, 2021 updated by: Chunling Jiang, West China Hospital

Association Between Early Extubation and Postoperative Complications After Liver Transplantation: A Retrospective Propensity Score-matched Analysis

This is a retrospective cohort study. Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study and divided into two groups. Operating room extubation group: early extubation in the operating room immediately following liver transplantation. Intensive care unit (ICU) extubation group: delay extubation in the ICU following liver transplantation. The primary objectives were to compare the incidence of composite outcome between the two groups. secondary objectives were to compare outcomes such as length of stay, hospital length of stay, and total cost between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study. Inclusion criteria: (1) adult patients (age ≥ 18 years), (2) undergoing liver transplantation. Exclusion criteria were the following: (1) re-transplantation; (2) multi-visceral transplantation; (3) intraoperative death; (4) severe encephalopathy (West Haven criteria III or IV); (5) those who had preoperative mechanical ventilation; (6) incomplete clinical data. The primary objectives was a composite of 30-day all-cause mortality, in-hospital AKI, or in-hospital moderate to severe pulmonary complications. Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery. The secondary objectives included in-hospital moderate to severe infectious complications, unplanned reintubation rates, ICU and postoperative hospital lengths of stay, and total hospital cost.

Study Type

Observational

Enrollment (Actual)

438

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study.

Description

Inclusion Criteria:

  • Adult patients (age ≥ 18 years)
  • Undergoing liver transplantation

Exclusion Criteria:

  • Re-transplantation
  • Multi-organ transplants
  • Intra-operative deaths
  • severe encephalopathy (West Haven criteria III or IV)
  • patients who had preoperative mechanical ventilation or fulminant hepatic failure
  • Incomplete clinical data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Operating room extubation group
extubation in the operating room immediately following liver transplantation
Procedure: extubation in the operating room
Patients who underwent liver transplantation early extubation in the operating room immediately following liver transplantation
ICU extubation group
extubation in the ICU following liver transplantation
Procedure: extubation in the ICU
Patients who underwent liver transplantation extubation in the ICU following liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of a composite of 30-day all-cause mortality, AKI and moderate to severe pulmonary complications.
Time Frame: through study completion, an average of 1 year
Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of moderate to severe infectious complications
Time Frame: 30 days
Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery
30 days
The incidence of re-intubation.
Time Frame: 30 days
Reintubation was defined as intubation after extubation of a patient who had been initially tracheal intubated under general anaesthesia
30 days
The length of hospital stay
Time Frame: through study completion, an average of 1 year
Length of hospital stay is the duration of a single episode of hospitalization
through study completion, an average of 1 year
The length of ICU stay
Time Frame: through study completion, an average of 1 year
Length of ICU stay is the duration of a single episode of ICU hospitalization
through study completion, an average of 1 year
The total hospital cost
Time Frame: 30 days
The total hospital cost
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2020

Primary Completion (ACTUAL)

April 15, 2020

Study Completion (ACTUAL)

April 15, 2020

Study Registration Dates

First Submitted

February 1, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (ACTUAL)

February 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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