Extubation in the Operating Room After Living Donor Liver Transplantation

Extubation in the Operating Room After Living Donor Liver Transplantation in Adult Patients: a Retrospective Observational Study

Duration of mechanical ventilation, length of intensive care unit stay, length of postoperative hospital stay, and the incidence rates of complications between the group with endotracheal tube extubation in the operating room (OR-EX) and those without (NOR-EX) in patients who underwent living-donor liver transplantation for end-stage liver failure are going to be compared. Through these results, it is investigated whether endotracheal tube extubation in the operating room is useful in reducing the length of stay in the intensive care unit and the hospital stay after surgery in patients who have undergone living-donor liver transplantation.

Study Overview

• Status: Completed
• Conditions: Extubation in the OR After LDLT
• Intervention / Treatment: Other: endotracheal tube extubation in the operating room

Detailed Description

Long-term mechanical ventilation after liver transplantation may increase the risk of complications such as pneumonia, sepsis, and multi-organ failure. Recent advances in surgical techniques and the introduction of short-acting anesthetics have accelerated the recovery of liver transplant recipients, and early extubation after liver transplantation is being proposed as a standard method. The results of a study on early extubation in patients undergoing liver transplantation suggested a reduction in the length of stay in the neutralizer room and predictors of early extubation. However, these studies are limited to males, and there is no study in which the definition of early extubation includes extubation in the operating room or extubation in the operating room within 1-3 hours of arrival in the intensive care unit.

• Study Type: Observational
• Enrollment (Actual): 277

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital

Participation Criteria

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

Adult patients 18 years of age or older who underwent living-donor liver transplantation for end-stage liver failure

Description

Inclusion Criteria:

• Adult patients 18 years of age or older who underwent living-donor liver transplantation for end-stage liver failure

Exclusion Criteria:

• A score of 26 or higher on the model for end-stage liver disease (MELD) scale
• In case of endotracheal intubation when entering the operating room
• If hepatic encephalopathy is stage 3 or higher at the time of admission to the operating room
• When the arterial blood partial pressure (PaO2)/inhaled oxygen fraction (FiO2) ratio is less than 200 on the Arterial Blood Gas Analysis (ABGA) before the end of the living liver transplantation operation
• Preoperative chest X-ray examination or chest computed tomography shows pulmonary edema
• If patients is diagnosed with hepatopulmonary syndrome before surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OR-EX; the group with endotracheal tube extubation in the operating room in patients who underwent living-donor liver transplantation for end-stage liver failure	Other: endotracheal tube extubation in the operating room; endotracheal tube extubation in the operating room
NOR-EX; the group without endotracheal tube extubation in the operating room in patients who underwent living-donor liver transplantation for end-stage liver failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of intensive care unit stay	length of intensive care unit stay	during intensive care unit stay, up to 3 months
length of postoperative hospital stay	length of postoperative hospital stay	during hospital stay, up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence rates of complications	incidence rates of complications	during admission, up to 6 months

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Hee Young Kim, MD, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): June 29, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 05-2021-052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No