Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients (VACARM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04408495
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment Phase
Postoperative Pulmonary Complications Procedure: Intervention group_MRA Procedure: Control group Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized, comparative, parallel-group trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : July 8, 2021
Estimated Primary Completion Date : August 8, 2023
Estimated Study Completion Date : July 8, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Intervention group_MRA
Recruitment maneuvers and high PEEP
Procedure: Intervention 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

Other Name: recruitment maneuvers

Active Comparator: Control group
No recruitment maneuvers and low PEEP
Procedure: Control 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.
Other Name: NO recruitment maneuvers




Primary Outcome Measures :
  1. Rate of major pulmonary complications and death [ 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


Secondary Outcome Measures :
  1. Rate of patients with hypotension [ Time Frame: intraoperative period ]
    Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers

  2. Evaluate the postoperative blood gases [ Time Frame: 30 minutes after extubation ]
    Measure of PaO2 (mmHg)

  3. Evaluate the postoperative blood gases [ Time Frame: 30 minutes after extubation ]
    Measure of HCO3 (mmol/l)

  4. Evaluate the postoperative blood gases [ Time Frame: 30 minutes after extubation ]
    Measure of PaCO2 (mmHg)

  5. Evaluate the postoperative blood gases [ Time Frame: 30 minutes after extubation ]
    Measure of SaO2 (%)

  6. Evaluate the postoperative blood gases [ Time Frame: Day 1 ]
    Measure of PaO2 (mmHg)

  7. Evaluate the postoperative blood gases [ Time Frame: Day 1 ]
    Measure of HCO3 (mmol/l)

  8. Evaluate the postoperative blood gases [ Time Frame: Day 1 ]
    Measure of PaCO2 (mmHg)

  9. Evaluate the postoperative blood gases [ Time Frame: Day 1 ]
    Measure of SaO2 (%)

  10. Evaluate the postoperative blood gases [ Time Frame: Day 2 ]
    Measure of PaO2 (mmHg)

  11. Evaluate the postoperative blood gases [ Time Frame: Day 2 ]
    Measure of HCO3 (mmol/l)

  12. Evaluate the postoperative blood gases [ Time Frame: Day 2 ]
    Measure of PaCO2 (mmHg)

  13. Evaluate the postoperative blood gases [ Time Frame: Day 2 ]
    Measure of SaO2 (%)

  14. Pulmonary function tests [ Time Frame: Day 0 ]
    Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry

  15. Pulmonary function tests [ Time Frame: Day 3 ]
    Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry

  16. Pulmonary function tests [ Time Frame: Day 5 ]
    Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry

  17. Daily evaluation of organ failure [ Time Frame: Up to 7 days ]
    SOFA score

  18. Daily evaluation of delirium [ Time Frame: Up to 7 days ]
    CAM-ICU scale

  19. Rate of Postoperative pulmonary complications (PPC) [ 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)

  20. Rate of Postoperative non pulmonary complications [ 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

  21. Ventilation duration, length of stay in ICU and in the study hospital and death [ Time Frame: Day 28 ]
    Number of Ventilatory-free days, vasopressor-free days, ICU-free days and hospital-free days

  22. Mortality rate [ Time Frame: Day 28 ]
  23. Mortality rate [ Time Frame: Day 90 ]
  24. Mortality rate [ Time Frame: Day 180 ]
  25. Biomarkers of systemic inflammation and of epithelial and endothelial aggression [ 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)

  26. Biomarkers of systemic inflammation and of epithelial and endothelial aggression [ 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408495


Contacts
Layout table for location contacts
Contact: Nathalie DEMAURE 299284321 nathalie.demaure@chu-rennes.fr
Contact: Nicolas NESSELER, Dr nicolas.nesseler@chu-rennes.fr

Locations
Layout table for location information
France
CHU Angers Not yet recruiting
Angers, France
Contact: Emmanuelle LONGEAU, Dr         
CHRU Brest Not yet recruiting
Brest, France
Contact: Jean-Ferréol OILLEAU, Dr         
CHU Poitiers Not yet recruiting
Poitiers, France
Contact: Thomas KERFONE, Dr         
CHU Rennes Recruiting
Rennes, France
Contact: Nathalie DEMAURE         
Principal Investigator: Nicolas NESSELER, Dr         
Principal Investigator: Nathalie DEMAURE         
CHU Nantes Not yet recruiting
Saint-Herblain, France
Contact: Bertrand ROZEC, Pr         
CHRU Tours Not yet recruiting
Tours, France
Contact: Fabien ESPITALIER, Dr         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Nathalie DEMAURE CHU Rennes
Principal Investigator: Nicolas NESSELER, Dr CHU Rennes
Principal Investigator: Jean-Ferréol OILLEAU, Dr CHRU Brest
Principal Investigator: Emmanuelle LONGEAU, Dr University Hospital, Angers
Principal Investigator: Bertrand ROZEC, Pr CHU Nantes
Principal Investigator: Thomas KERFONE, Dr CHU Poitiers
Principal Investigator: Fabien ESPITALIER, Dr CHRU Tours
Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04408495    
Other Study ID Numbers: 35RC18_8854_VACARM
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
recruitment maneuvers
Postoperative pulmonary complications
Peep
Cardiac surgery
Mortality