Analysis of Risk Factors and Establishment of Early Warni... | NCT04967651

Studies
Analysis of Risk Factors and Establishment of Early Warning Model for Pulmonary Complications

NCT04967651

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Nov 3, 2021Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Postoperative Pulmonary Complications

Interventions

Not provided

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 23, 2021Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jul 15, 2021

First Submission Date that Met QC Criteria

Jul 15, 2021

First Posted Date

Jul 19, 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

Oct 26, 2021

Last Update Posted Date

Nov 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Collaborators

Name	Class
Wuhan Central Hospital	OTHER
Shanxi Cardiovascular Hospital	OTHER
Qinghai People's Hospital	OTHER

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

The purpose of this study is to collect perioperative diagnosis and treatment information for cardiac surgery patients, collect blood samples for laboratory testing when necessary, and analyze the data to clarify the risk factors of pulmonary complications in patients undergoing cardiac surgery during the perioperative period. On this basis, a clinical early warning model for pulmonary complications after cardiac surgery will be developed to reduce the risk of pulmonary complications and even death in clinical practice.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with pulmonary complications following cardiac surgery
Patients without pulmonary complications following cardiac surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The occurrence of postoperative pulmonary complications		1 week after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients aged 18 years or older;
Elective cardiac surgery under general anesthesia

Exclusion Criteria:

Patients and their family members refused to be enrolled;
Patients unable to communicate due to language barriers such as dementia;
Patients admitted to ICU 24h before surgery;
Estimated duration of surgery less than 2 hours;
Patients died or discharged within 24 hours after surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients aged 18 years or older who planned elective cardiac surgery under general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qingping Wu	Contact	13971605283		wqp1968@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wuhan Union Hospital	Recruiting	Wuhan			China