Perioperative Risk Factors Related to the Prognosis of Lung Transplantation: A Retrospective Study

April 21, 2025 updated by: Diansan Su, Zhejiang University
This study analyzes patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University from 2017 to 2024, focusing on anesthesia's impact on post-op results. It gathers patient data from hospital and Mediston systems, with main focus on in-hospital complications and secondary focus on ICU stay, post-op hospitalization, mortality, and intubation time. The research aims to deepen understanding of anesthetic management's role in lung transplant outcomes and guide improvements in perioperative anesthesia protocols.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • HangZhou, Zhejiang, China, 310000
        • The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, zhejiang 310000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University between January 2017 and October 2024

Description

Inclusion Criteria:

  • Age >18 years at time of transplantation
  • Received single or bilateral lung transplantation

Exclusion Criteria:

  • Re-transplantation
  • Multi-organ transplantation
  • Autotransplantation
  • Incomplete medical records: Recipients with >20% missing essential data elements in any of these categories:Preoperative baseline characteristics； Intraoperative parameters；Postoperative outcome measures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Lung transplantation group
In this group, we collected perioperative clinical data and analyzed risk factors associated with patient outcomes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In-hospital adverse events
Time Frame: Collect data for an expected average about 2 hours
In-hospital adverse events were defined as post-transplant complications occurring prior to discharge, such as: Grade 3 PGD, respiratory infections, stroke, cardiac events, AKI, or liver impairment.
Collect data for an expected average about 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ICU stay
Time Frame: Collect data for an expected average about 2 hours
The ICU stay （days） was calculated from the time of ICU admission after surgery completion to actual discharge from the intensive care unit
Collect data for an expected average about 2 hours
Postoperative hospital stay
Time Frame: Collect data for an expected average about 2 hours
Postoperative hospital（days）stay after lung transplantation
Collect data for an expected average about 2 hours
In-hospital mortality
Time Frame: Collect data for an expected average about 2 hours
The proportion of patients who died during the initial hospitalization period following lung transplantation surgery
Collect data for an expected average about 2 hours
30-day postoperative mortality
Time Frame: Collect data for an expected average about 2 hours
Number of deaths within 30 days post-transplant) / (Total number of lung transplant recipients) × 100%；
Collect data for an expected average about 2 hours
90-day postoperative mortality
Time Frame: Collect data for an expected average about 2 hours
Number of deaths within 90 days post-transplant) / (Total number of lung transplant recipients) × 100%
Collect data for an expected average about 2 hours
The duration of endotracheal intubation
Time Frame: Collect data for an expected average about 2 hours
Duration of intubation should be recorded from surgery end-time to extubation
Collect data for an expected average about 2 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Grade 3 Primary Graft Dysfunction (PGD)
Time Frame: Collect data for an expected average about 2 hours
PGD3:A ratio of arterial oxygen partial pressure to fraction of inspired oxygen (PaO₂/FiO₂) < 200 mmHg with bilateral infiltrates on chest radiograph, or Requirement for extracorporeal life support (ECLS) within 72 hours postoperatively, or use of inhaled pulmonary vasodilators for >48 hours during mechanical ventilation.
Collect data for an expected average about 2 hours
Pulmonary Infection
Time Frame: Collect data for an expected average about 2 hours
Radiologically confirmed by a staff radiologist as new or progressive pulmonary infiltrates on: Chest X-ray or Computed tomography (CT) scan
Collect data for an expected average about 2 hours
Acute Kidney Injury
Time Frame: Collect data for an expected average about 2 hours
A rise in serum creatinine >120 μmol/L
Collect data for an expected average about 2 hours
Cardiovascular Events
Time Frame: Collect data for an expected average about 2 hours
Acute myocardial infarction； heart failure；Cardiovascular hemorrhage；Clinically significant arrhythmias；Conduction system disorders；Cardiac arrest；Refractory hypotension due to cardiogenic sock.
Collect data for an expected average about 2 hours
Hepatic Dysfunction
Time Frame: Collect data for an expected average about 2 hours
Aspartate aminotransferase (AST) >34 or Alanine aminotransferase (ALT) >40 U/L;
Collect data for an expected average about 2 hours
Cerebral Infarction
Time Frame: Collect data for an expected average about 2 hours
Diagnosed by staff radiologists as new or progressive ischemic lesions on CT or MRI
Collect data for an expected average about 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZJU2025B0268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings