Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-25 @ 12:41 PM
Study NCT ID:
NCT04408495
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2020-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, randomized, comparative, parallel-group trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2020-05-25', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of major pulmonary complications and death', 'timeFrame': '28 days after surgery', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Rate of patients with hypotension', 'timeFrame': 'intraoperative period', 'description': 'Safety criteria with Hypotension lasting more than 60 seconds after the end of the recruitment maneuvers'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': '30 minutes after extubation', 'description': 'Measure of PaO2 (mmHg)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': '30 minutes after extubation', 'description': 'Measure of HCO3 (mmol/l)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': '30 minutes after extubation', 'description': 'Measure of PaCO2 (mmHg)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': '30 minutes after extubation', 'description': 'Measure of SaO2 (%)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': 'Day 1', 'description': 'Measure of PaO2 (mmHg)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': 'Day 1', 'description': 'Measure of HCO3 (mmol/l)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': 'Day 1', 'description': 'Measure of PaCO2 (mmHg)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': 'Day 1', 'description': 'Measure of SaO2 (%)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': 'Day 2', 'description': 'Measure of PaO2 (mmHg)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': 'Day 2', 'description': 'Measure of HCO3 (mmol/l)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': 'Day 2', 'description': 'Measure of PaCO2 (mmHg)'}, {'measure': 'Evaluate the postoperative blood gases', 'timeFrame': 'Day 2', 'description': 'Measure of SaO2 (%)'}, {'measure': 'Pulmonary function tests', 'timeFrame': 'Day -1 or Day 0', 'description': 'Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry'}, {'measure': 'Pulmonary function tests', 'timeFrame': 'Day 3', 'description': 'Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry'}, {'measure': 'Pulmonary function tests', 'timeFrame': 'Day 5', 'description': 'Measure of vital capacity (CV) and maximum expiratory volume by second (VEMS) by spirometry'}, {'measure': 'Daily evaluation of organ failure', 'timeFrame': 'Up to 7 days', 'description': 'SOFA score'}, {'measure': 'Daily evaluation of delirium', 'timeFrame': 'Up to 7 days', 'description': 'CAM-ICU scale'}, {'measure': 'Rate of Postoperative pulmonary complications (PPC)', 'timeFrame': 'within the 28 days after surgery', 'description': '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)'}, {'measure': 'Rate of Postoperative non pulmonary complications', 'timeFrame': 'within the 28 days after surgery', 'description': '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'}, {'measure': 'Ventilation duration, length of stay in ICU and in the study hospital and death', 'timeFrame': 'Day 28', 'description': 'Number of Ventilatory-free days, vasopressor-free days, Renal Replacement Therapy free days, ICU-free days and hospital-free days'}, {'measure': 'Mortality rate', 'timeFrame': 'Day 28'}, {'measure': 'Mortality rate', 'timeFrame': 'Day 90'}, {'measure': 'Mortality rate', 'timeFrame': 'Day 180'}, {'measure': 'Biomarkers of systemic inflammation and of epithelial and endothelial aggression', 'timeFrame': 'Day 0', 'description': 'Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)'}, {'measure': 'Biomarkers of systemic inflammation and of epithelial and endothelial aggression', 'timeFrame': 'Day 1', 'description': 'Plasma levels of TNFα, IL1β, IL6, IL8 et IL10, Angiopoeitin 2 and soluble form of receptor for advanced glycation end products (sRAGE)'}, {'measure': 'Length of stay in ICU and in the study hospital', 'timeFrame': 'Day 180', 'description': 'Number of days in ICU and in the study hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recruitment maneuvers', 'Postoperative pulmonary complications', 'Peep', 'Cardiac surgery', 'Mortality'], 'conditions': ['Postoperative Pulmonary Complications']}, 'referencesModule': {'references': [{'pmid': '41161829', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years-old,\n* Evaluated before cardiopulmonary bypass for any cardiac surgical procedure (e.g. coronary artery bypass grafting, valve, aorta, or combined procedures),\n* With a pulmonary risk score ≥ 2\n* Who gave written informed consent\n* affiliated to a social security system\n\nExclusion Criteria:\n\n* BMI \\> 40kg/m2 ;\n* Left Ventricular Ejection Fraction \\< 35% ;\n* Preoperative shock ;\n* Aortic surgery with planned circulatory arrest ;\n* Minimally invasive cardiac surgery ;\n* Emergency surgery with patient unable to give written informed consent\n* Heart transplantation\n* Mechanical circulatory support surgery\n* Pregnant or lactating women\n* Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty'}, 'identificationModule': {'nctId': 'NCT04408495', 'acronym': 'VACARM', 'briefTitle': 'Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '35RC18_8854_VACARM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group_MRA', 'description': 'Recruitment maneuvers and high PEEP', 'interventionNames': ['Procedure: Intervention group_MRA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'No recruitment maneuvers and low PEEP', 'interventionNames': ['Procedure: Control group']}], 'interventions': [{'name': 'Intervention group_MRA', 'type': 'PROCEDURE', 'otherNames': ['recruitment maneuvers'], 'description': '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.\n\nRecruitment maneuvers are performed in accordance with the surgical team an if SAP≥90 mmHg or MAP≥65 mmHg.\n\nVentilation is maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O', 'armGroupLabels': ['Intervention group_MRA']}, {'name': 'Control group', 'type': 'PROCEDURE', 'otherNames': ['NO recruitment maneuvers'], 'description': '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.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Nancy', 'country': 'France', 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Herblain', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Nathalie DEMAURE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rennes'}, {'name': 'Nicolas NESSELER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rennes'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data availability after the primary publication of the results and until the database is deleted', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}