Extubation in the OR After LDLTNCT04963309
Extubation in the Operating Room After Living Donor Liver Transplantation
An observational study of Extubation in the OR After LDLT, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation in the OR After LDLT
- What is being tested?
- endotracheal tube extubation in the operating room
- How many people
- 277 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2021to 29 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients 18 years of age or older who underwent living-donor liver transplantation for end-stage liver failure
Who may be able to join
- Adult patients 18 years of age or older who underwent living-donor liver transplantation for end-stage liver failure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Extubation in the OR After LDLT
- Being tested
- endotracheal tube extubation in the operating room
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal tube extubation in the operating roomOther
endotracheal tube extubation in the operating room
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of intensive care unit stay
length of intensive care unit stay
Measured: during intensive care unit stay, up to 3 months
length of postoperative hospital stay
length of postoperative hospital stay
Measured: during hospital stay, up to 6 months
Secondary outcomes (1)
incidence rates of complications
incidence rates of complications
Measured: during admission, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Mar 2021
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation in the OR After LDLTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963309
- Sponsor's protocol ID
- 05-2021-052
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extubation in the Operating Room After Living Donor Liver Transplantation in Adult Patients: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04963309
- Acronym / sponsor ID
- 05-2021-052
- Conditions
- Extubation in the OR After LDLT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OR-EX | – | Other: endotracheal tube extubation in the operating roomthe group with endotracheal tube extubation in the operating room in patients who underwent living-donor liver transplantation for end-stage liver failure |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients 18 years of age or older who underwent living-donor liver transplantation for end-stage liver failure
Key inclusion criteria (1 listed)
- Adult patients 18 years of age or older who underwent living-donor liver transplantation for end-stage liver failure
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotracheal tube extubation in the operating roomendotracheal tube extubation in the operating room | Other | OR-EX |
Primary outcome
length of intensive care unit stay
Time frame: during intensive care unit stay, up to 3 months
length of intensive care unit stay
length of postoperative hospital stay
Time frame: during hospital stay, up to 6 months
length of postoperative hospital stay
1 secondary outcome
incidence rates of complications
Time frame: during admission, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Young Kim, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation in the OR After LDLT, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of intensive care unit stay (time frame: during intensive care unit stay, up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.