- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05439811
Retrospective Data Analysis on the Application of Swan-Ganz Catheter in Cardiac Surgery
June 30, 2022 updated by: Shanglong Yao, Huazhong University of Science and Technology
The investigators aimed to investigate postoperative complications associated with Swan-Ganz Catheter based on the clinical data of Wuhan Union Hospital and Wuhan Asian heart hospital for 10 years, including major cardiovascular, respiratory adverse events, ICU time, mechanical ventilation time, length of hospital stay, in-hospital mortality, and 30-day postoperative mortality events.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
3000
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults undergoing cardiac surgery
Description
Inclusion Criteria:
- Over 18 years old;
- Patients undergoing major cardiac surgery under general anesthesia;
- Patients with complete sex, age, use of floating catheter and prognosis data
Exclusion Criteria:
- ASA grade V and above;
- End stage renal disease requiring (or undergoing) renal replacement therapy;
- Pregnant or lactating women
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 |
|---|---|---|
|
Number of participants with cardiovascular events
Time Frame: one week after operation
|
1) Cardiac death; 2) Non fatal myocardial infarction; 3) Intra aortic balloon counterpulsation (IABP); 4) Thoracotomy exploration; 5) Heart failure.
|
one week after operation
|
|
Number of participants respiratory adverse events
Time Frame: one week after operation
|
1) Acute lung injury: Diagnosis according to Berlin diagnostic standard; 2) Atelectasis: X-ray confirmed with body temperature >37.5c or abnormal pulmonary manifestations; 3) Pneumothorax: chest X-ray diagnosis; 4) Pneumonia: confirmed by radiology or bacteriology
|
one week after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 (Anticipated)
June 30, 2022
Primary Completion (Anticipated)
June 30, 2025
Study Completion (Anticipated)
December 30, 2025
Study Registration Dates
First Submitted
June 21, 2022
First Submitted That Met QC Criteria
June 26, 2022
First Posted (Actual)
June 30, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
June 30, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGCS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
If the patient's privacy information is not involved, you can contact the research team by email to obtain data (yaoshanglong@hust.edu.cn)
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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