Extubation in the Operating Room After Living Donor Liver Transplantation

Completed

• Conditions: Extubation in the OR After LDLT
• Interventions: Other: endotracheal tube extubation in the operating room

• Registration Number: NCT04963309
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29
• Study First Submitted: 2021-06-29
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OR-EX	endotracheal tube extubation in the operating room	the group with endotracheal tube extubation in the operating room in patients who underwent living-donor liver transplantation for end-stage liver failure

Primary Outcome Measures

Name	Time	Method
length of intensive care unit stay	during intensive care unit stay, up to 3 months	length of intensive care unit stay
length of postoperative hospital stay	during hospital stay, up to 6 months	length of postoperative hospital stay

Secondary Outcome Measures

Name	Time	Method
incidence rates of complications	during admission, up to 6 months	incidence rates of complications

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of