Clinical trial NCT04261816: Early Extubation and Postoperative Complications After Liver Transplantation
Official title: Association Between Early Extubation and Postoperative Complications After Liver Transplantation: A Retrospective Propensity Score-matched Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of a composite of 30-day all-cause mortality, AKI and moderate to severe pulmonary complications.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The incidence of moderate to severe infectious complications
timeFrame: 30 days
measure: The incidence of re-intubation.
timeFrame: 30 days
measure: The length of hospital stay
timeFrame: through study completion, an average of 1 year
measure: The length of ICU stay
timeFrame: through study completion, an average of 1 year
measure: The total hospital cost
timeFrame: 30 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
citation: 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.