Clinical trial NCT04963309: Extubation in the Operating Room After Living Donor Liver Transplantation
Official title: Extubation in the Operating Room After Living Donor Liver Transplantation in Adult Patients: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extubation in the OR After LDLT
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 277
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: Adult patients 18 years of age or older who underwent living-donor liver transplantation for end-stage liver failure

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.

Eligibility criteria: 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

Primary outcomes:
measure: length of intensive care unit stay
timeFrame: during intensive care unit stay, up to 3 months
measure: length of postoperative hospital stay
timeFrame: during hospital stay, up to 6 months
Secondary outcomes:
measure: incidence rates of complications
timeFrame: during admission, up to 6 months
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Hee Young Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: