Early Extubation and Postoperative Complications After Liver Transplantation

NCT04261816 — Completed, 438 participants, West China Hospital

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

RegistryNCT04261816
StatusCompleted
Study typeObservational
Enrollment438 (Actual)
SponsorWest China Hospital (Other)
ConditionsLiver Transplantation
Interventionsextubation in the operating room, extubation in the ICU (Procedure)
Datesstart 2020-01-15, primary completion 2020-04-15, completion 2020-04-15, first posted 2020-02-10, last updated 2021-06-10
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Liver Transplantation All trials of extubation in the operating room All trials of extubation in the ICU

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Operating room extubation groupProcedure: extubation in the operating roomextubation in the operating room immediately following liver transplantation
ICU extubation groupProcedure: extubation in the ICUextubation in the ICU following liver transplantation
  • extubation in the operating room (Procedure): Patients who underwent liver transplantation early extubation in the operating room immediately following liver transplantation
  • extubation in the ICU (Procedure): Patients who underwent liver transplantation extubation in the ICU following liver transplantation

+Outcome measures

Primary outcomes

  • The incidence of a composite of 30-day all-cause mortality, AKI and moderate to severe pulmonary complications. [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

Secondary outcomes

  • The incidence of moderate to severe infectious complications [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
  • The incidence of re-intubation. [30 days]: Reintubation was defined as intubation after extubation of a patient who had been initially tracheal intubated under general anaesthesia
  • The length of hospital stay [through study completion, an average of 1 year]: Length of hospital stay is the duration of a single episode of hospitalization
  • The length of ICU stay [through study completion, an average of 1 year]: Length of ICU stay is the duration of a single episode of ICU hospitalization
  • The total hospital cost [30 days]: The total hospital cost

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
West China HospitalChengdu, SichuanChina

+Publications

  • Results publication: 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