The Effect of Perioperative Factors on Postoperative Outc... | NCT06603350

Studies
The Effect of Perioperative Factors on Postoperative Outcomes After Lung Transplantation

NCT06603350

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Postoperative Complications After Lung Transplantation

Interventions

No intenvention

Countries

China

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 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2024Actual

Primary Completion Date

Feb 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Sep 5, 2024

First Submission Date that Met QC Criteria

Sep 17, 2024

First Posted Date

Sep 19, 2024Actual

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

Sep 17, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intenvention	Other	No intenvention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prosedure of lung transplantation, Aged more than 18 years old

Exclusion Criteria:

Secondary lung transplantation, multiple organ transplantation, refusal to participate

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

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine	Recruiting	Hangzhou	Zhejiang	330100	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided