Extubation in the Operating Room After Living Donor Liver... | NCT04963309

Studies
Extubation in the Operating Room After Living Donor Liver Transplantation

NCT04963309

Sponsor

Pusan National University Yangsan Hospital

Status

Completed

Last Update Posted

Jul 15, 2021Actual

Enrollment

277Actual

Phase

Not provided

Conditions

Extubation in the OR After LDLT

Interventions

endotracheal tube extubation in the operating room

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jun 29, 2021Actual

Completion Date

Jun 29, 2021Actual

First Submitted Date

Jun 29, 2021

First Submission Date that Met QC Criteria

Jul 7, 2021

First Posted Date

Jul 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2021

Last Update Posted Date

Jul 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kim Hee Young, Clinical associate professor, Pusan National University Yangsan HospitalPrincipal Investigator

Lead Sponsor

Pusan National University Yangsan HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

277Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endotracheal tube extubation in the operating room	Other	endotracheal tube extubation in the operating room	OR-EX

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hee Young Kim, MD, PhD	Pusan National University Yangsan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Yangsan Hospital		Yangsan			South Korea