Postoperative Pulmonary Complications
Conditions
Keywords
recruitment maneuvers, Postoperative pulmonary complications, Peep, Cardiac surgery, Mortality
Brief summary
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
Detailed description
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
Interventions
PROCEDUREIntervention group_MRA
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
PROCEDUREControl group
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.
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Multicenter, randomized, comparative, parallel-group trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years-old, * Evaluated before cardiopulmonary bypass for any cardiac surgical procedure (e.g. coronary artery bypass grafting, valve, aorta, or combined procedures), * With a pulmonary risk score ≥ 2 * Who gave written informed consent * affiliated to a social security system
Exclusion criteria
* BMI \> 40kg/m2 ; * Left Ventricular Ejection Fraction \< 35% ; * Preoperative shock ; * Aortic surgery with planned circulatory arrest ; * Minimally invasive cardiac surgery ; * Emergency surgery with patient unable to give written informed consent * Heart transplantation * Mechanical circulatory support surgery * Pregnant or lactating women * Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of major pulmonary complications and death | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with hypotension | intraoperative period | Safety criteria with Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers |
| Evaluate the postoperative blood gases | 30 minutes after extubation | Measure of PaO2 (mmHg) |
| Pulmonary function tests | Day -1 or Day 0 | Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry |
| Daily evaluation of organ failure | Up to 7 days | SOFA score |
| Daily evaluation of delirium | Up to 7 days | CAM-ICU scale |
| Rate of Postoperative pulmonary complications (PPC) | 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) |
| Rate of Postoperative non pulmonary complications | 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 |
| Ventilation duration, length of stay in ICU and in the study hospital and death | Day 28 | Number of Ventilatory-free days, vasopressor-free days, Renal Replacement Therapy free days, ICU-free days and hospital-free days |
| Mortality rate | Day 28 | — |
| Biomarkers of systemic inflammation and of epithelial and endothelial aggression | Day 0 | Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE) |
| Length of stay in ICU and in the study hospital | Day 180 | Number of days in ICU and in the study hospital |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORNathalie DEMAURE
CHU Rennes
PRINCIPAL_INVESTIGATORNicolas NESSELER, MD
CHU Rennes
Outcome results
None listed