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Controversies remain concerning the best intraoperative mechanical ventilation regimen for major cardiac surgery. While the use of intra operative low tidal volumes is now standard practice, the optimal level of positive end-expiratory pressure (PEEP) and the use of recruitment maneuvers (RM) remain controversial. The aim of this study is to compare two regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac surgery patients at risk of postoperative pulmonary complications
In this randomized controlled trial, cardiac surgery patients at risk of postoperative pulmonary complications will be assigned to intraoperative ventilation with high PEEP and RM or intraoperative mechanical ventilation with low PEEP and without RM. The primary endpoint will be a composite endpoint including major postoperative complications within the first postoperative week and death within the 28 days after surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group_MRA | Experimental | Recruitment maneuvers and high PEEP |
|
| Control group | Active Comparator | No recruitment maneuvers and low PEEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group_MRA | Procedure | Tidal Volume (Vt) =6-8 mL/kg of predicted body weight (PBW), Peep=8 cmH2O, recruitment maneuvers=30cm H2O every 30 min after intubation (except during CPB), after any disconnection and at the admission in ICU. Recruitment maneuvers are performed in accordance with the surgical team an if SAP≥90 mmHg or MAP≥65 mmHg. Ventilation is maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of major pulmonary complications and death | Major pulmonary complications, defined as prolonged mechanical ventilation >24h post-operatively, pneumonia (defined according to the 2017 French guidelines) or reintubation for any cause within 7 post-operative days, or death | 28 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with hypotension | Safety criteria with Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers | intraoperative period |
| Evaluate the postoperative blood gases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie DEMAURE | Rennes University Hospital | Principal Investigator |
| Nicolas NESSELER, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Amiens | France | ||||
| CHRU Brest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41161829 | Derived | Demaure N, Le Cunff J, Duchene M, Rozec B, Espitalier F, Cabon JM, Oilleau JF, Guerci P, Labaste F, Abou-Arab O, Guinot PG, Duval P, Besnier E, Flecher E, Leroyer I, Morcet J, Fougerou-Leurent C, Mansour A, Nesseler N; VACARM investigators; ATLANREA study group. Impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients: the VACARM randomised clinical trial-study protocol. BMJ Open. 2025 Oct 29;15(10):e104179. doi: 10.1136/bmjopen-2025-104179. |
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All of the individual participant data collected during the trial will be available, after the primary publication of the results, to any researchers who provide a methodologically sound proposal. Proposals should be directed to dri@chu-rennes.fr. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.
Data availability after the primary publication of the results and until the database is deleted
Any researchers who provide a methodologically sound proposal will be able to access the IPD ans supporting information. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.
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Multicenter, randomized, comparative, parallel-group trial
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|
|
| Control group | Procedure | Vt=6-8 mL/kg of PBW, Peep=5 cmH2O , No recruitment maneuvers. Ventilation maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O. |
|
|
Measure of PaO2 (mmHg)
| 30 minutes after extubation |
| Evaluate the postoperative blood gases | Measure of HCO3 (mmol/l) | 30 minutes after extubation |
| Evaluate the postoperative blood gases | Measure of PaCO2 (mmHg) | 30 minutes after extubation |
| Evaluate the postoperative blood gases | Measure of SaO2 (%) | 30 minutes after extubation |
| Evaluate the postoperative blood gases | Measure of PaO2 (mmHg) | Day 1 |
| Evaluate the postoperative blood gases | Measure of HCO3 (mmol/l) | Day 1 |
| Evaluate the postoperative blood gases | Measure of PaCO2 (mmHg) | Day 1 |
| Evaluate the postoperative blood gases | Measure of SaO2 (%) | Day 1 |
| Evaluate the postoperative blood gases | Measure of PaO2 (mmHg) | Day 2 |
| Evaluate the postoperative blood gases | Measure of HCO3 (mmol/l) | Day 2 |
| Evaluate the postoperative blood gases | Measure of PaCO2 (mmHg) | Day 2 |
| Evaluate the postoperative blood gases | Measure of SaO2 (%) | Day 2 |
| Pulmonary function tests | Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry | Day -1 or Day 0 |
| Pulmonary function tests | Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry | Day 3 |
| Pulmonary function tests | Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry | Day 5 |
| Daily evaluation of organ failure | SOFA score | Up to 7 days |
| Daily evaluation of delirium | CAM-ICU scale | Up to 7 days |
| Rate of Postoperative pulmonary complications (PPC) | Pneumonia (defined according to the 2017 French guidelines), re-intubation within 7 days, mechanical ventilation >24h, pneumothorax, Atelectasis, Acute Respiratory Distress Syndrome. PPC grade (according to Huzelbos et al; JAMA) | within the 28 days after surgery |
| Rate of Postoperative non pulmonary complications | Re intervention for acute bleeding, Pericardial Tamponade, Sternal wound infection, Ventricular Arrhythmia, Atrial fibrillation, Myocardial infarction, Mesenteric ischemia, Sepsis/septic shock, Acute kidney injury with renal replacement therapy | within the 28 days after surgery |
| Ventilation duration, length of stay in ICU and in the study hospital and death | Number of Ventilatory-free days, vasopressor-free days, Renal Replacement Therapy free days, ICU-free days and hospital-free days | Day 28 |
| Mortality rate | Day 28 |
| Mortality rate | Day 90 |
| Mortality rate | Day 180 |
| Biomarkers of systemic inflammation and of epithelial and endothelial aggression | Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE) | Day 0 |
| Biomarkers of systemic inflammation and of epithelial and endothelial aggression | Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE) | Day 1 |
| Length of stay in ICU and in the study hospital | Number of days in ICU and in the study hospital | Day 180 |
| Brest |
| France |
| CHU de Dijon | Dijon | France |
| CHU de Nancy | Nancy | France |
| CHU Poitiers | Poitiers | France |
| CHU Rennes | Rennes | France |
| CHU de Rouen | Rouen | France |
| CHU Nantes | Saint-Herblain | France |
| CHU de Toulouse | Toulouse | France |
| CHRU Tours | Tours | France |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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