The Effect of Perioperative Factors on Postoperative Outcomes After Lung Transplantation

September 17, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

The Effect of Perioperative Factors on Postoperative Outcomes in Patients Undergoing Lung Transplantation: a Prospective Observational Study

  1. Evaluate the influence of perioperative factors on postoperative outcomes in patients undergoing lung transplantation patients.
  2. To evaluate the feasibility of using pulmonary ultrasound to identify lung complications such as atelectasis and pulmonary edema after lung transplantation
  3. Observe the changes of perioperative inflammation and immune indexes after lung transplantation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 330100
        • Recruiting
        • Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Inclusion Criteria are adult patients undergoing lung transplantation Those undergoing retransplantation,multiple organ transplantation or refusal to participate will be excluded.

Description

Inclusion Criteria:

Prosedure of lung transplantation, Aged more than 18 years old

Exclusion Criteria:

Secondary lung transplantation, multiple organ transplantation, refusal to participate

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulmonary complications
Time Frame: 3 days after surgery
Incidence of atelectasis and primary graft dysfunction(PGD) detcted by lung ultrasound
3 days after surgery
Mortality
Time Frame: 1 year after surgery
Survival rate after lung transplantation
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory index IL-6
Time Frame: 3 days after after surgery
Variation of perioperative inflammatory index IL-6
3 days after after surgery

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, 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 (Actual)

July 28, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0764

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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