Postoperative Mechanical Ventilation TimeNCT06012955
Study on the Effect of Target-controlled Infusion for General Anesthesia in Cardiac Surgery
An observational study of Postoperative Mechanical Ventilation Time, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of the study was to evaluate whether individualized general anesthesia with target-controlled infusion could help patients wake up early for extubation and reduce the incidence of postoperative complications, and to investigate the effectiveness and safety of its application in patients undergoing cardiac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Mechanical Ventilation Time
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2023to 30 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or olderundergoing cardiac surgery under general anesthesia
Who may be able to join
- All patients aged 18 years and older who underwent cardiac surgery
Who cannot join
- Mechanical ventilation support before surgery;
- Combined with any type of non-cardiac surgeries;
- Second exploratory thoracotomy after surgery;
- Died or discharged within 48 h after surgery;
- Missing clinical data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
Qingping Wu, 13971605283, wqp1968@163.com
About this study
Official title: Study on the Effect of Target-controlled Infusion of Propofol and Remifentanil for Patients Undergoing Cardiac Surgery
The purpose of the study was to evaluate whether individualized general anesthesia with target-controlled infusion could help patients wake up early for extubation and reduce the incidence of postoperative complications, and to investigate the effectiveness and safety of its application in patients undergoing cardiac surgery.
- Being tested
- Target-controlled infusion (TCI) systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target-controlled infusion (TCI) systemsDevice
Target-controlled infusion (TCI) with propofol and remifentanil was used for anesthesia induction and maintenance
| Study group | Role | What they receive |
|---|---|---|
| TCI group | patients receiving general anesthesia using target-controlled infusion delivery system Receives: Device: Target-controlled infusion (TCI) systems | |
| MCI group | patients receiving general anesthesia using conventional manual controlled infusion delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative mechanical ventilation
Duration of mechanical ventilation was defined as the time from the end of surgery to tracheal extubation
Measured: 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Mechanical Ventilation TimeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012955
- Sponsor's protocol ID
- TCI202112
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Target-controlled Infusion of Propofol and Remifentanil for Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06012955
- Acronym / sponsor ID
- TCI202112
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Aug 2023 (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 purpose of the study was to evaluate whether individualized general anesthesia with target-controlled infusion could help patients wake up early for extubation and reduce the incidence of postoperative complications, and to investigate the effectiveness and safety of its application in patients undergoing cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCI group | – | Device: Target-controlled infusion (TCI) systemspatients receiving general anesthesia using target-controlled infusion delivery system |
| MCI group | – | –patients receiving general anesthesia using conventional manual controlled infusion delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or olderundergoing cardiac surgery under general anesthesia
Key inclusion criteria (1 listed)
- All patients aged 18 years and older who underwent cardiac surgery
Key exclusion criteria (5 listed)
- Mechanical ventilation support before surgery;
- Combined with any type of non-cardiac surgeries;
- Second exploratory thoracotomy after surgery;
- Died or discharged within 48 h after surgery;
- Missing clinical data
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 |
|---|---|---|
| Target-controlled infusion (TCI) systemsTarget-controlled infusion (TCI) with propofol and remifentanil was used for anesthesia induction and maintenance | Device | TCI group |
Primary outcome
Duration of postoperative mechanical ventilation
Time frame: 4 weeks after surgery
Duration of mechanical ventilation was defined as the time from the end of surgery to tracheal extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Mechanical Ventilation Time, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 1 inclusion and 5 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Qingping Wu (13971605283, wqp1968@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative mechanical ventilation (time frame: 4 weeks after surgery). 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 28 Aug 2023.