Cardiac SurgeryCAPVNINCT02302300
Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery
A study testing Manufacturer STELLAR 150 in people with Cardiac Surgery, run by University Hospital, Brest at 1 site in France.
Trial summary
After cardiac surgery, many complications can arise, in particular at the cardiac and lung level and it is true especially as the patient is with comorbidity. A patient will be considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity, Chronic obstructive pulmonary disease (COPD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Manufacturer STELLAR 150
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2014to 26 Feb 2019
- Phase
- Interventional
- 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
Who may be able to join
- Every patient of more than 18 years, programmed for a cardiac surgery ( valve replacement, coronary bypass, aortic surgery) in the service of "Chirurgie Cardio-Thoracique et Vasculaire" (CCTV) of the CHRU of Brest
- and obesity (BMI > 30 kg/m2
- and/or COPD (stages 1-2 and 3, classification GOLD)
- and/or restrictive syndrome (CPT 80 %)
- and/or cardiac insufficiency (FEVG 55 %)
- and/or syndrome of obesity-hypoventilation not requiring an equipment
- and/or Syndrome of sleep apnea not requiring an equipment
Who cannot join
- Patients having a contraindication absolved from the NIV
- Patients carrier of a neuro-muscular disease
- Patients carrier of a syndrome of sleep apnea and/or COPD, and sailed
- Hypercapnic patients (with a limit value of PaCO2 > 55 mm Hg)
- Unaffiliated patients to a social diet of safety
- Patients under guardianship or under guardianship
- Patient who can not follow the NIV program as well as the patients of whom the consent was not collected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery, in Disease Prevention of the Cardiac and/or Lung Complications at the Patients at Risk.
After cardiac surgery, many complications can arise, in particular at the cardiac and lung level and it is true especially as the patient is with comorbidity. A patient will be considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity, Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive ventilation (NIV)developed these last years in the treatment of acute cardiac insufficiency and the hypercapnic COPD exacerbations; its use is more and more envisaged in cardio-thoracic and abdominal surgery services.
Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and a decrease of ventilation work. According to these observations, the preventive NIV could reduce the incidence of appearance of the lung and/or cardiac complications at the patients to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect to obtain a benefit with this particular population. If we meet our goal (a significant difference in terms of morbi-mortality with the preventive NIV versus classical care), we expect the systematisation of this procedure to all cardiac surgery high risk patients.
- Conditions
- Cardiac Surgery
- Being tested
- Manufacturer STELLAR 150
- Keywords
- Cardiac surgery, Preventive non-invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manufacturer STELLAR 150Device
5 days of non-invasive ventilation at two levels of pressure from it pre-operative, followed by 5 days in post-operative.
| Study group | Role | What they receive |
|---|---|---|
| Manufacturer STELLAR 150 | Experimental | 5 days of non-invasive ventilation at two levels of pressure from it pre-operative, followed by 5 days in post-operative. Receives: Device: Manufacturer STELLAR 150 |
| Control Group | No intervention | Standard preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of cardio-pulmonary complications in postoperative cardiac surgery
Appearance of cardio-pulmonary complications in postoperative cardiac surgery among the complications listed below:
- Atelectasis
- Acute respiratory insufficiency
- Acute cardiac insufficiency
- Pneumothorax
- Arrhythmia
- Myocardial infarction
- Cardiac tamponade
Measured: 1 month
Secondary outcomes (1)
Determine postoperative mortality; length of stay in intensive care, length of stay in the service of CCTV
Measured: 1 and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study start27 May 2014
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis COUTURAUD, Pr, Principal investigator, Département de Médecine Interne et de Pneumologie, CHU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302300
- Sponsor's protocol ID
- 29BRC13.0125
- Acronym
- CAPVNI
- Status last verified
- Feb 2025
- First submitted
- 29 Jul 2014
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goret M, Pluchon K, Le Mao R, Badra A, Oilleau JF, Morvan Y, Beaumont M, Desanglois G, Guegan M, Barnier A, Gut-Gobert C, Tromeur C, Leroyer C, Choplain JN, Khalifa A, Bezon E, Couturaud F. Impact of Noninvasive Ventilation Before and After Cardiac Surgery for Preventing Cardiac and Pulmonary Complications: A Clinical Randomized Trial. Chest. 2025 Jun;167(6):1727-1736. doi: 10.1016/j.chest.2025.02.010. Epub 2025 Feb 19.
PubMed 39984118
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery, in Disease Prevention of the Cardiac and/or Lung Complications at the Patients at Risk.
- ClinicalTrials.gov ID
- NCT02302300
- Acronym / sponsor ID
- CAPVNI / 29BRC13.0125
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac surgery, Preventive non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 May 2014 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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.
After cardiac surgery, many complications can arise, in particular at the cardiac and lung level and it is true especially as the patient is with comorbidity. A patient will be considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity, Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive ventilation (NIV)developed these last years in the treatment of acute cardiac insufficiency and the hypercapnic COPD exacerbations; its use is more and more envisaged in cardio-thoracic and abdominal surgery services.
Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and a decrease of ventilation work. According to these observations, the preventive NIV could reduce the incidence of appearance of the lung and/or cardiac complications at the patients to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect to obtain a benefit with this particular population. If we meet our goal (a significant difference in terms of morbi-mortality with the preventive NIV versus classical care), we expect the systematisation of this procedure to all cardiac surgery high risk patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manufacturer STELLAR 150 | Experimental | Device: Manufacturer STELLAR 1505 days of non-invasive ventilation at two levels of pressure from it pre-operative, followed by 5 days in post-operative. |
| Control Group | No intervention | –Standard preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Every patient of more than 18 years, programmed for a cardiac surgery ( valve replacement, coronary bypass, aortic surgery) in the service of "Chirurgie Cardio-Thoracique et Vasculaire" (CCTV) of the CHRU of Brest
- and obesity (BMI > 30 kg/m2
- and/or COPD (stages 1-2 and 3, classification GOLD)
- and/or restrictive syndrome (CPT 80 %)
- and/or cardiac insufficiency (FEVG 55 %)
Key exclusion criteria (7 listed)
- Patients having a contraindication absolved from the NIV
- Patients carrier of a neuro-muscular disease
- Patients carrier of a syndrome of sleep apnea and/or COPD, and sailed
- Hypercapnic patients (with a limit value of PaCO2 > 55 mm Hg)
- Unaffiliated patients to a social diet of safety
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 |
|---|---|---|
| Manufacturer STELLAR 1505 days of non-invasive ventilation at two levels of pressure from it pre-operative, followed by 5 days in post-operative. | Device | Manufacturer STELLAR 150 |
Primary outcome
Appearance of cardio-pulmonary complications in postoperative cardiac surgery
Time frame: 1 month
Appearance of cardio-pulmonary complications in postoperative cardiac surgery among the complications listed below: * Atelectasis * Acute respiratory insufficiency * Acute cardiac insufficiency * Pneumothorax * Arrhythmia * Myocardial infarction * Cardiac tamponade
1 secondary outcome
Determine postoperative mortality; length of stay in intensive care, length of stay in the service of CCTV
Time frame: 1 and 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 39984118Goret M, Pluchon K, Le Mao R, Badra A, Oilleau JF, Morvan Y, Beaumont M, Desanglois G, Guegan M, Barnier A, Gut-Gobert C, Tromeur C, Leroyer C, Choplain JN, Khalifa A, Bezon E, Couturaud F. Impact of Noninvasive Ventilation Before and After Cardiac Surgery for Preventing Cardiac and Pulmonary Complications: A Clinical Randomized Trial. Chest. 2025 Jun;167(6):1727-1736. doi: 10.1016/j.chest.2025.02.010. Epub 2025 Feb 19.
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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.
Francis COUTURAUD, Pr principal investigator
Département de Médecine Interne et de Pneumologie, CHU BREST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manufacturer STELLAR 150 in people with Cardiac Surgery, run by University Hospital, Brest at 1 site in France.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 6 Feb 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Appearance of cardio-pulmonary complications in postoperative cardiac surgery (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302300, which also lists 1 linked publication.
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 Feb 2025.