Postoperative ComplicationsNCT05439811
Retrospective Data Analysis on the Application of Swan-Ganz Catheter in Cardiac Surgery
An observational study of Postoperative Complications, run by Huazhong University of Science and Technology.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Swan-Ganz Catheter
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults undergoing cardiac surgery
Who may be able to join
- Over 18 years old;
- Patients undergoing major cardiac surgery under general anesthesia;
- Patients with complete sex, age, use of floating catheter and prognosis data
Who cannot join
- ASA grade V and above;
- End stage renal disease requiring (or undergoing) renal replacement therapy;
- Pregnant or lactating women
About this study
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.
- Conditions
- Postoperative Complications
- Being tested
- Swan-Ganz Catheter
- Keywords
- Swan-Ganz Catheter, Cardiac Surgery, Postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swan-Ganz CatheterProcedure or surgery
Swan-Ganz Catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with cardiovascular events
- Cardiac death; 2) Non fatal myocardial infarction; 3) Intra aortic balloon counterpulsation (IABP); 4) Thoracotomy exploration; 5) Heart failure.
Measured: one week after operation
Number of participants respiratory adverse events
- 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
Measured: one week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start30 Jun 2022 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Asia Heart Hospital
- Responsible party
- Principal investigator, Shanglong Yao, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439811
- Sponsor's protocol ID
- SGCS
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Individual data sharing
- Undecided: If the patient's privacy information is not involved, you can contact the research team by email to obtain data (yaoshanglong@hust.edu.cn)
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Analysis on the Application of Swan-Ganz Catheter in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05439811
- Acronym / sponsor ID
- SGCS
- Conditions
- Postoperative Complications
- Keywords
- Swan-Ganz Catheter, Cardiac Surgery, Postoperative complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan Asia Heart Hospital
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing cardiac surgery
Key inclusion criteria (3 listed)
- Over 18 years old;
- Patients undergoing major cardiac surgery under general anesthesia;
- Patients with complete sex, age, use of floating catheter and prognosis data
Key exclusion criteria (3 listed)
- ASA grade V and above;
- End stage renal disease requiring (or undergoing) renal replacement therapy;
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swan-Ganz CatheterSwan-Ganz Catheter | Procedure or surgery | – |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: Undecided. If the patient's privacy information is not involved, you can contact the research team by email to obtain data (yaoshanglong@hust.edu.cn)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with cardiovascular events (time frame: one week after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.