Cardiopulmonary BypassVECARNCT03372174
Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery
A study testing Maintaining mechanical ventilation during surgery and Absence of mechanical ventilation during surgery in people with Cardiopulmonary Bypass, run by Rennes University Hospital at 6 sites in France.
Trial summary
The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- Maintaining mechanical ventilation during surgery and Absence of mechanical ventilation during surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,401 participants
- Where
- 6 sitesFrance
- Study dates
- 10 Jan 2018to 30 Jul 2021
- 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
- Age ≥ 18 years old;
- Scheduled for any cardiac surgery (elective surgery) with cardio-pulmonary bypass, aortic clamp and cardioplegia, with median sternotomy and bi-pulmonary ventilation (cardiac valvular surgery (valve replacement or repair), coronary artery surgery, ascending aortic surgery and/or combined);
- Written informed consent.
Who cannot join
- Emergency surgery ;
- Planned thoracotomy with one lung ventilation ;
- Patients with known respiratory diseases (current respiratory infections, asthma, chronic obstructive or restrictive pulmonary disease, obstructive apnea syndrome) ;
- Patients already intubated in the peri-operative period ;
- Immunodepression defined by proven humoral or cellular deficiency, by continuous administration of steroids at any dose for more than one month prior to hospitalization, high-dose steroids (> 15 mg / kg / day of methylprednisolone or Equivalent), radiotherapy or chemotherapy in the previous year;;
- Need for vasopressor or inotropic agents before surgery ;
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- Any acute infection in the last month before surgery ;
- Hematological disorder, autoimmune disease, immunodeficiency, immunosuppressive therapy ;
- Heart failure with an left ventricular ejection fraction<35% ;
- Protected person (adults legally protected (under judicial protection, guardianship, or supervision), person deprived of their liberty.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Angers
Angers
CHU Bordeaux
Bordeaux
CHU Lille
Lille
Hôpital Pitié Salpêtrière
Paris
CHU Rennes
Rennes
CHU Toulouse
Toulouse
About this study
Official title: Beneficial Effects on Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery on Postoperative Infections
The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.
Read the detailed description
Cardiopulmonary bypass (CBP) during cardiac surgery induces a systemic inflammatory response associated with an immune dysregulation and a significant pulmonary dysfunction. First, the inflammatory response, usually attributed to surgical trauma, contact of blood with artificial surfaces, and ischemia reperfusion injury, is responsible for a postoperative immunodepression. For instance, an early impairment of lung cellular immune response after CPB, which could promote the development of postoperative pneumonia, has been found. Along these lines, a downregulation of human leukocyte antigen-DR antigen (HLA-DR) expression on monocytes and an increase in plasma interleukin 10 (IL-10) associated with the occurrence of nosocomial infections have been reported. Second, CPB induces a pulmonary dysfunction, which ranges from a temporary and clinically insignificant reduction in arterial oxygenation to a life-threatening injury manifested as acute respiratory distress syndrome (ARDS). This phenomenon is of multifactorial sources, but one of the main mechanisms is the occurrence of atelectasis during surgery. Atelectasis has been associated with lung injury and release of cytokines by shear forces on alveoli and small airways. However, it is not clear whether this injury is due to a recruitment/derecruitment phenomenon (i.e., atelectrauma) or whether it might by itself lead to the release of cytokine. Since CPB mechanically circulates and oxygenates blood bypassing the heart and lungs, usual procedure during CPB is to stop mechanical ventilation (MV) (apnea). Nevertheless, maintaining MV with positive expiratory pressure (PEEP) during CPB diminished the occurrence of atelectasis and the postoperative inflammatory response. Thus, we investigated the effects of maintaining MV during CPB for cardiac surgery on postoperative immunodepression and found that maintaining MV during CPB decreased postoperative immune dysfunction and could be an interesting strategy to diminish the occurrence of postoperative infection (nosocomial infection) without hampering the surgical procedure. However, these findings have to be confirmed in a clinical trial using the incidence of nosocomial infection as an endpoint.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Maintaining mechanical ventilation during surgery, Absence of mechanical ventilation during surgery
- Keywords
- cardiac surgery, mechanical ventilation, postoperative infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintaining mechanical ventilation during surgeryDevice
dead space ventilation using tidal volume of 2.5 mL/kg/pbw (predicted body weight) with 5-7 cm H2O Positive end-expiratory pressure
Absence of mechanical ventilation during surgeryDevice
absence of mechanical ventilation (and no Positive end-expiratory pressure) by disconnecting the tracheal tube from the ventilator
| Study group | Role | What they receive |
|---|---|---|
| Mechanical ventilation group | Experimental | patients with mechanical ventilation during cardiopulmonary bypass for cardiac surgery Receives: Device: Maintaining mechanical ventilation during surgery |
| Control group | Active comparator | patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery Receives: Device: Absence of mechanical ventilation during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative infections
Measured: During 28 days
Secondary outcomes (12)
Expression of human leukocyte antigen-DR antigen (HLA-DR)
Measured: At day 0, day 1 and day 7
Plasmatic concentration of interleukin 10 (IL10)
Measured: At day 0, day 1 and day 7
Indoleamine 2,3-Dioxygenase (IDO) activity
Measured: At day 0, day 1 and day 7
Proportion of myeloid-derived suppressor cells (MDSCs)
Measured: At day 0, day 1 and day 7
Plasmatic concentration of interleukin 6 (IL-6)
Measured: At day 0, day 1 and day 7
Quantity of extracellular vesicles (EV)
Measured: At day 0 and day 1
Occurrence of lymphopenia
Measured: At day 0, day 1 and day 7
Duration of antibiotic treatment
Measured: During 28 days
Mortality
Measured: During 28 days
Length of hospital stay
Measured: During 28 days
PaO2/FiO2 ratio
Measured: At day 0 and day 1
Duration of mechanical ventilation
Measured: During 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start10 Jan 2018
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
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 Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc TADIE, Principal investigator, Rennes Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372174
- Sponsor's protocol ID
- 35RC16_9908_VECAR
- Other IDs
- 2017-A01246-47
- Acronym
- VECAR
- Status last verified
- Apr 2022
- First submitted
- 4 Dec 2017
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tadie JM, Ouattara A, Laviolle B, Lesouhaitier M, Esvan M, Rousseau C, Gregoire M, Gaudriot B, Nesseler N, Labaste F, Sanchez P, Marcheix B, Beurton A, Dureau P, Demondion P, Fouquet O, Rineau E, Amour J, Verhoye JP, Mercat A, Terzi N, Tarte K, Bougle A, Flecher E; VECAR Trial Group and REVA. Maintaining ventilation with very low tidal volume and positive-end expiratory pressure versus no ventilation during cardiopulmonary bypass for cardiac surgery in adults: a randomized clinical trial. Intensive Care Med. 2025 May;51(5):849-860. doi: 10.1007/s00134-025-07901-5. Epub 2025 May 5.
PubMed 40323450
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects on Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery on Postoperative Infections
- ClinicalTrials.gov ID
- NCT03372174
- Acronym / sponsor ID
- VECAR / 35RC16_9908_VECAR
- Conditions
- Cardiopulmonary Bypass
- Keywords
- cardiac surgery, mechanical ventilation, postoperative infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,401 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 13 Dec 2017 (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 main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.
Detailed description
Cardiopulmonary bypass (CBP) during cardiac surgery induces a systemic inflammatory response associated with an immune dysregulation and a significant pulmonary dysfunction. First, the inflammatory response, usually attributed to surgical trauma, contact of blood with artificial surfaces, and ischemia reperfusion injury, is responsible for a postoperative immunodepression. For instance, an early impairment of lung cellular immune response after CPB, which could promote the development of postoperative pneumonia, has been found. Along these lines, a downregulation of human leukocyte antigen-DR antigen (HLA-DR) expression on monocytes and an increase in plasma interleukin 10 (IL-10) associated with the occurrence of nosocomial infections have been reported. Second, CPB induces a pulmonary dysfunction, which ranges from a temporary and clinically insignificant reduction in arterial oxygenation to a life-threatening injury manifested as acute respiratory distress syndrome (ARDS). This phenomenon is of multifactorial sources, but one of the main mechanisms is the occurrence of atelectasis during surgery. Atelectasis has been associated with lung injury and release of cytokines by shear forces on alveoli and small airways. However, it is not clear whether this injury is due to a recruitment/derecruitment phenomenon (i.e., atelectrauma) or whether it might by itself lead to the release of cytokine. Since CPB mechanically circulates and oxygenates blood bypassing the heart and lungs, usual procedure during CPB is to stop mechanical ventilation (MV) (apnea). Nevertheless, maintaining MV with positive expiratory pressure (PEEP) during CPB diminished the occurrence of atelectasis and the postoperative inflammatory response. Thus, we investigated the effects of maintaining MV during CPB for cardiac surgery on postoperative immunodepression and found that maintaining MV during CPB decreased postoperative immune dysfunction and could be an interesting strategy to diminish the occurrence of postoperative infection (nosocomial infection) without hampering the surgical procedure. However, these findings have to be confirmed in a clinical trial using the incidence of nosocomial infection as an endpoint.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical ventilation group | Experimental | Device: Maintaining mechanical ventilation during surgerypatients with mechanical ventilation during cardiopulmonary bypass for cardiac surgery |
| Control group | Active comparator | Device: Absence of mechanical ventilation during surgerypatients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old;
- Scheduled for any cardiac surgery (elective surgery) with cardio-pulmonary bypass, aortic clamp and cardioplegia, with median sternotomy and bi-pulmonary ventilation (cardiac valvular surgery (valve replacement or repair), coronary artery surgery, ascending aortic surgery and/or combined);
- Written informed consent.
Key exclusion criteria (10 listed)
- Emergency surgery ;
- Planned thoracotomy with one lung ventilation ;
- Patients with known respiratory diseases (current respiratory infections, asthma, chronic obstructive or restrictive pulmonary disease, obstructive apnea syndrome) ;
- Patients already intubated in the peri-operative period ;
- Immunodepression defined by proven humoral or cellular deficiency, by continuous administration of steroids at any dose for more than one month prior to hospitalization, high-dose steroids (> 15 mg / kg / day of methylprednisolone or Equivalent), radiotherapy or chemotherapy in the previous year;;
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 |
|---|---|---|
| Maintaining mechanical ventilation during surgerydead space ventilation using tidal volume of 2.5 mL/kg/pbw (predicted body weight) with 5-7 cm H2O Positive end-expiratory pressure | Device | Mechanical ventilation group |
| Absence of mechanical ventilation during surgeryabsence of mechanical ventilation (and no Positive end-expiratory pressure) by disconnecting the tracheal tube from the ventilator | Device | Control group |
Primary outcome
Incidence of postoperative infections
Time frame: During 28 days
12 secondary outcomes
Expression of human leukocyte antigen-DR antigen (HLA-DR)
Time frame: At day 0, day 1 and day 7
Plasmatic concentration of interleukin 10 (IL10)
Time frame: At day 0, day 1 and day 7
Indoleamine 2,3-Dioxygenase (IDO) activity
Time frame: At day 0, day 1 and day 7
Proportion of myeloid-derived suppressor cells (MDSCs)
Time frame: At day 0, day 1 and day 7
Plasmatic concentration of interleukin 6 (IL-6)
Time frame: At day 0, day 1 and day 7
Quantity of extracellular vesicles (EV)
Time frame: At day 0 and day 1
Occurrence of lymphopenia
Time frame: At day 0, day 1 and day 7
Duration of antibiotic treatment
Time frame: During 28 days
Mortality
Time frame: During 28 days
Length of hospital stay
Time frame: During 28 days
PaO2/FiO2 ratio
Time frame: At day 0 and day 1
Duration of mechanical ventilation
Time frame: During 28 days
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 2 May 2022.
- Derived from this study: PubMed 40323450Tadie JM, Ouattara A, Laviolle B, Lesouhaitier M, Esvan M, Rousseau C, Gregoire M, Gaudriot B, Nesseler N, Labaste F, Sanchez P, Marcheix B, Beurton A, Dureau P, Demondion P, Fouquet O, Rineau E, Amour J, Verhoye JP, Mercat A, Terzi N, Tarte K, Bougle A, Flecher E; VECAR Trial Group and REVA. Maintaining ventilation with very low tidal volume and positive-end expiratory pressure versus no ventilation during cardiopulmonary bypass for cardiac surgery in adults: a randomized clinical trial. Intensive Care Med. 2025 May;51(5):849-860. doi: 10.1007/s00134-025-07901-5. Epub 2025 May 5.
- Individual participant dataSharing planned: No
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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.
Jean-Marc TADIE principal investigator
Rennes Hospital University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintaining mechanical ventilation during surgery and Absence of mechanical ventilation during surgery in people with Cardiopulmonary Bypass, run by Rennes University Hospital at 6 sites 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 3 inclusion and 10 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Incidence of postoperative infections (time frame: During 28 days). 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 NCT03372174, 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 2 May 2022.