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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05439811
Other study ID # SGCS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 30, 2022
Est. completion date December 30, 2025

Study information

Verified date June 2022
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date December 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Swan-Ganz Catheter
Swan-Ganz Catheter

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Huazhong University of Science and Technology Wuhan Asia Heart Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with cardiovascular events 1) Cardiac death; 2) Non fatal myocardial infarction; 3) Intra aortic balloon counterpulsation (IABP); 4) Thoracotomy exploration; 5) Heart failure. one week after operation
Primary Number of participants respiratory adverse events 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
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