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OpenTrials
Completed

NCT Number: NCT04963309

Extubation in the Operating Room After Living Donor Liver Transplantation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Yangsan Hospital

Yangsan, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endotracheal tube extubation in the operating room

Other

endotracheal tube extubation in the operating room

Primary outcomes

  1. length of intensive care unit stay

    Time frame: during intensive care unit stay, up to 3 months

    length of intensive care unit stay

  2. length of postoperative hospital stay

    Time frame: during hospital stay, up to 6 months

    length of postoperative hospital stay

Secondary outcomes

  1. incidence rates of complications

    Time frame: during admission, up to 6 months

    incidence rates of complications

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2021
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.