Post-operative Cardiac SurgeryNCT05050435
Early Cardiac Extubation After Cardiac Surgery
An observational study of Post-operative Cardiac Surgery, run by University of Liege at 1 site in Belgium.
Trial summary
The management of heart valve disease is constantly evolving over time. The minimally invasive approach (mini-thoracotomy and J-hemisternotomy) is one of the major surgical evolutions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Cardiac Surgery
- What is being tested?
- Early extubation
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Aug 2021to 31 Dec 2021
- 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: We included all the patients who have had minimally invasive valve replacement surgery in our service
Who may be able to join
- Minimally invasive valve replacement intervention (thoracotomy or J-hemisternotomy)
Who cannot join
- Combined surgery
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
ULiege - CHU
Liège, 4000
Océane Jaquet, 0032479760411, jaquet.oceane@gmail.com
About this study
Official title: Early Cardiac Extubation After Cardiac Surgery: a Retrospective Single-center Non-inferiority Trial
The management of heart valve disease is constantly evolving over time. The minimally invasive approach (mini-thoracotomy and J-hemisternotomy) is one of the major surgical evolutions. It has many advantages including, among others, a reduction of postoperative pain and the preservation of sternal stability This evolution of the surgical technique towards a less invasive approach encouraged the investigators to adapt the anesthetic management accordingly. In particular, immediate postoperative extubation appeared feasible. The investigators would therefore like to test the hypothesis that immediate extuation is non-inferior to delayed extubation with regard to patient safety. The investigators also investigated whether immediate extubation could be beneficiel in terms of vasopressors requirement, risk of early postoperative complications, fluid balance and length of stay in the intesive care unit and in the hopsital.
- Conditions
- Post-operative Cardiac Surgery
- Being tested
- Early extubation
- Keywords
- post-operative complications, on table extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early extubationProcedure or surgery
Patients of the 2 groups are extubated at different moments: either immediately postoperatively, in the operating room, or after a few hours monitoring in ICU
| Study group | Role | What they receive |
|---|---|---|
| Early extubated (in operating room) patients after valvular cardiac surgery | Not described Receives: Procedure: Early extubation | |
| Later extubated (in ICU) patients after valvular cardiac surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
Intensive care unit length of stay (days)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start30 Aug 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Cardiac SurgeryStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050435
- Sponsor's protocol ID
- Ulganescardio001
- Status last verified
- Oct 2021
- First submitted
- 30 Aug 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Cardiac Extubation After Cardiac Surgery: a Retrospective Single-center Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05050435
- Acronym / sponsor ID
- Ulganescardio001
- Conditions
- Post-operative Cardiac Surgery
- Keywords
- post-operative complications, on table extubation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Sep 2021 (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 management of heart valve disease is constantly evolving over time. The minimally invasive approach (mini-thoracotomy and J-hemisternotomy) is one of the major surgical evolutions. It has many advantages including, among others, a reduction of postoperative pain and the preservation of sternal stability This evolution of the surgical technique towards a less invasive approach encouraged the investigators to adapt the anesthetic management accordingly. In particular, immediate postoperative extubation appeared feasible. The investigators would therefore like to test the hypothesis that immediate extuation is non-inferior to delayed extubation with regard to patient safety. The investigators also investigated whether immediate extubation could be beneficiel in terms of vasopressors requirement, risk of early postoperative complications, fluid balance and length of stay in the intesive care unit and in the hopsital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early extubated (in operating room) patients after valvular cardiac surgery | – | Procedure: Early extubation |
| Later extubated (in ICU) patients after valvular cardiac surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included all the patients who have had minimally invasive valve replacement surgery in our service
Key inclusion criteria (1 listed)
- Minimally invasive valve replacement intervention (thoracotomy or J-hemisternotomy)
Key exclusion criteria (1 listed)
- Combined surgery
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 |
|---|---|---|
| Early extubationPatients of the 2 groups are extubated at different moments: either immediately postoperatively, in the operating room, or after a few hours monitoring in ICU | Procedure or surgery | Early extubated (in operating room) patients after valvular cardiac surgery |
Primary outcome
Post-operative complications
Time frame: 30 days
Intensive care unit length of stay (days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Post-operative Cardiac Surgery, run by University of Liege at 1 site in Belgium.
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 1 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 14 Oct 2021. 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 Belgium. 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 Oceane Jaquet (0032479760411, jaquet.oceane@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications (time frame: 30 days). 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 14 Oct 2021.