NCT Number: NCT04408495
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
CHU Amiens-Picardie, Amiens, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: recruitment maneuvers
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.
Other names: NO recruitment maneuvers
Time frame: 28 days after surgery
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
Time frame: intraoperative period
Safety criteria with Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers
Time frame: 30 minutes after extubation
Measure of PaO2 (mmHg)
Time frame: 30 minutes after extubation
Measure of HCO3 (mmol/l)
Time frame: 30 minutes after extubation
Measure of PaCO2 (mmHg)
Time frame: 30 minutes after extubation
Measure of SaO2 (%)
Time frame: Day 1
Measure of PaO2 (mmHg)
Time frame: Day 1
Measure of HCO3 (mmol/l)
Time frame: Day 1
Measure of PaCO2 (mmHg)
Time frame: Day 1
Measure of SaO2 (%)
Time frame: Day 2
Measure of PaO2 (mmHg)
Time frame: Day 2
Measure of HCO3 (mmol/l)
Time frame: Day 2
Measure of PaCO2 (mmHg)
Time frame: Day 2
Measure of SaO2 (%)
Time frame: Day -1 or Day 0
Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
Time frame: Day 3
Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
Time frame: Day 5
Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry
Time frame: Up to 7 days
SOFA score
Time frame: Up to 7 days
CAM-ICU scale
Time frame: within the 28 days after surgery
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)
Time frame: within the 28 days after surgery
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
Time frame: Day 28
Number of Ventilatory-free days, vasopressor-free days, Renal Replacement Therapy free days, ICU-free days and hospital-free days
Time frame: Day 28
Time frame: Day 90
Time frame: Day 180
Time frame: Day 0
Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)
Time frame: Day 1
Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)
Time frame: Day 180
Number of days in ICU and in the study hospital
Rennes University Hospital
Other
Effect of IntraoperatiVe High Positive End-ExpirAtory Pressure (PEEP) With ReCruitment MAneuveRs vs Low PEEP on Major Postoperative Pulmonary Complications and Death After On-pump Cardiac Surgery in High-risk Patients: the VACARM Study
Acronym: VACARM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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