Early Extubation and Postoperative Complications After Liver Transplantation

NCT04261816 | Completed

• 1 other identifier: 2020-014
• Study Type: observational
• Target: 438
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• The incidence of a composite of 30-day all-cause mortality, AKI and 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

  through study completion, an average of 1 year

Secondary Outcomes (5)

• The incidence of moderate to severe infectious complications

  30 days

• The incidence of re-intubation.

  30 days

• The length of hospital stay

  through study completion, an average of 1 year

• The length of ICU stay

  through study completion, an average of 1 year

• The total hospital cost

  30 days

Study Arms (2)

Operating room extubation group

extubation in the operating room immediately following liver transplantation

Procedure: extubation in the operating room

ICU extubation group

extubation in the ICU following liver transplantation

Procedure: extubation in the ICU

Interventions

extubation in the operating room PROCEDURE

Patients who underwent liver transplantation early extubation in the operating room immediately following liver transplantation

Operating room extubation group

extubation in the ICU PROCEDURE

Patients who underwent liver transplantation extubation in the ICU following liver transplantation

ICU extubation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, China

Location

Related Publications (1)

• Xu Y, Zuo Y, Zhou L, Hao X, Xiao X, Ye M, Bo L, Jiang C, Yang J. Extubation in the operating room results in fewer composite mechanical ventilation-related adverse outcomes in patients after liver transplantation: a retrospective cohort study. BMC Anesthesiol. 2021 Nov 18;21(1):286. doi: 10.1186/s12871-021-01508-1.

  PMID: 34794387 DERIVED

MeSH Terms

Interventions

Airway Extubation

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 10, 2020
• Study Start: January 15, 2020
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: June 10, 2021

Record last verified: 2021-04

Locations

CN (1)