. 2025 Oct 29;15(10):e104179.

doi: 10.1136/bmjopen-2025-104179.

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

Nathalie Demaure¹, Jehanne Le Cunff¹, Maryline Duchêne², Bertrand Rozec³, Fabien Espitalier⁴, Jean-Michel Cabon⁵, Jean-Ferréol Oilleau⁶, Philippe Guerci⁷, François Labaste⁸, Osama Abou-Arab⁹, Pierre-Grégoire Guinot¹⁰, Pierre Duval¹¹, Emmanuel Besnier¹¹, Erwan Flécher¹², Isabelle Leroyer¹³, Jeff Morcet¹⁴, Claire Fougerou-Leurent^{15

16}, Alexandre Mansour¹⁷, Nicolas Nesseler¹⁸; VACARM investigators; ATLANREA study group

Collaborators, Affiliations

Collaborators

VACARM investigators:
Lauren Caro, Samia Kara Mostefa, Thomas Klein, Aymeric Marin, Grégoire Le Gac, Sébastien Biedermann, Pauline Guette, Baptiste Gaudriot, Etienne Delaval, Vincent Pey, Pascale Sanchez
ATLANREA study group:
Antoine Roquilly, Yoann Launey, Sigismond Lasocki, Olivier Langeron, Claire Dahyot-Fizelier

Affiliations

¹ Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), Department of Anesthesia and Critical Care, Pontchaillou, Rennes University Hospital, Rennes, Brittany, France.
² Department of Anesthesia and Critical Care, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.
³ Department of Anesthesia and Critical Care, Laënnec Hospital, University Hospital of Nantes and Nantes Université, CHU Nantes, CNRS, INSERM, l'institut du thorax, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.
⁴ Department of Anesthesia and Critical Care, Regional University Hospital Centre Tours, Tours, Centre-Val de Loire, France.
⁵ Department of Anesthesia and Critical Care, CHU de Brest, Brest, Brittany, France.
⁶ Département d'Anesthésie et Réanimation Chirurgicale, Brest University Hospital Centre, Brest, Brittany, France.
⁷ Department of Anesthesia and Critical Care, CHU de Nancy, Nancy, Lorraine, France.
⁸ Department of Anesthesia and Critical Care, University Hospital of Toulouse, Toulouse, France.
⁹ Department of Anesthesia and Critical Care, Amiens-Picardy University Hospital, Amiens, Hauts-de-France, France.
¹⁰ Burgundy Franche-Comté University, Besancon, France.
¹¹ Department of Anesthesia and Critical Care, University Hospital Centre Rouen, Rouen, Normandy, France.
¹² Cardiothoracic Surgery Unit, Centre Hospitalier Universitaire de Rennes, Rennes, Bretagne, France.
¹³ Univ Rennes, CHU de Rennes, Department of Research and Innovation, University Hospital of Rennes, Rennes University Hospital, Rennes, Brittany, France.
¹⁴ Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), F-35000 Rennes, Rennes University Hospital, Rennes, Brittany, France.
¹⁵ Pharmacology, University Hospital Centre Rennes, Rennes, France.
¹⁶ CIC 1414, INSERM, Rennes, France.
¹⁷ Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), Inra, Inserm, Institut NUMECAN - UMR_A 1341, UMR_S 1241, Department of Anesthesia and Critical Care, Pontchaillou, University Hospital of Rennes, F-35000 Rennes, Rennes University Hospital, Rennes, France.
¹⁸ Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), Inra, Inserm, Institut NUMECAN - UMR_A 1341, UMR_S 1241, Department of Anesthesia and Critical Care, Pontchaillou, Rennes University Hospital, Rennes, Brittany, France nicolas.nesseler@chu-rennes.fr.

PMID: 41161829
PMCID: PMC12574407
DOI: 10.1136/bmjopen-2025-104179

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

Nathalie Demaure et al. BMJ Open. 2025.

. 2025 Oct 29;15(10):e104179.

doi: 10.1136/bmjopen-2025-104179.

Authors

Collaborators

VACARM investigators:
Lauren Caro, Samia Kara Mostefa, Thomas Klein, Aymeric Marin, Grégoire Le Gac, Sébastien Biedermann, Pauline Guette, Baptiste Gaudriot, Etienne Delaval, Vincent Pey, Pascale Sanchez
ATLANREA study group:
Antoine Roquilly, Yoann Launey, Sigismond Lasocki, Olivier Langeron, Claire Dahyot-Fizelier

Affiliations

¹ Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), Department of Anesthesia and Critical Care, Pontchaillou, Rennes University Hospital, Rennes, Brittany, France.
² Department of Anesthesia and Critical Care, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.
³ Department of Anesthesia and Critical Care, Laënnec Hospital, University Hospital of Nantes and Nantes Université, CHU Nantes, CNRS, INSERM, l'institut du thorax, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.
⁴ Department of Anesthesia and Critical Care, Regional University Hospital Centre Tours, Tours, Centre-Val de Loire, France.
⁵ Department of Anesthesia and Critical Care, CHU de Brest, Brest, Brittany, France.
⁶ Département d'Anesthésie et Réanimation Chirurgicale, Brest University Hospital Centre, Brest, Brittany, France.
⁷ Department of Anesthesia and Critical Care, CHU de Nancy, Nancy, Lorraine, France.
⁸ Department of Anesthesia and Critical Care, University Hospital of Toulouse, Toulouse, France.
⁹ Department of Anesthesia and Critical Care, Amiens-Picardy University Hospital, Amiens, Hauts-de-France, France.
¹⁰ Burgundy Franche-Comté University, Besancon, France.
¹¹ Department of Anesthesia and Critical Care, University Hospital Centre Rouen, Rouen, Normandy, France.
¹² Cardiothoracic Surgery Unit, Centre Hospitalier Universitaire de Rennes, Rennes, Bretagne, France.
¹³ Univ Rennes, CHU de Rennes, Department of Research and Innovation, University Hospital of Rennes, Rennes University Hospital, Rennes, Brittany, France.
¹⁴ Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), F-35000 Rennes, Rennes University Hospital, Rennes, Brittany, France.
¹⁵ Pharmacology, University Hospital Centre Rennes, Rennes, France.
¹⁶ CIC 1414, INSERM, Rennes, France.
¹⁷ Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), Inra, Inserm, Institut NUMECAN - UMR_A 1341, UMR_S 1241, Department of Anesthesia and Critical Care, Pontchaillou, University Hospital of Rennes, F-35000 Rennes, Rennes University Hospital, Rennes, France.
¹⁸ Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), Inra, Inserm, Institut NUMECAN - UMR_A 1341, UMR_S 1241, Department of Anesthesia and Critical Care, Pontchaillou, Rennes University Hospital, Rennes, Brittany, France nicolas.nesseler@chu-rennes.fr.

PMID: 41161829
PMCID: PMC12574407
DOI: 10.1136/bmjopen-2025-104179

Abstract

Introduction: Postoperative pulmonary complications (PPCs) are common after cardiac surgery and are associated with significant morbidity and mortality. Lung-protective ventilation strategies have been proposed to reduce PPCs, but the optimal level of positive end-expiratory pressure (PEEP) and the use of alveolar recruitment manoeuvres (RMs) remain controversial.

Methods/analysis: In this investigator-initiated, multicentre, open, randomised, parallel-group, superiority clinical trial, elective cardiac surgery patients at risk of PPCs will be assigned to one of two intraoperative ventilation strategies: (1) an open-lung ventilation strategy with protective ventilation, moderate PEEP and RMs or (2) a standard protective ventilation with low PEEP and no RM. The primary outcome will be a composite of prolonged (>24 hour) postoperative mechanical ventilation, reintubation for any cause or hospital-acquired pneumonia within 7 days of surgery, or death within 28 days of surgery. Data will be analysed on an intention-to-treat basis.

Ethics and dissemination: The VACARM (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) trial has been approved by an independent ethics committee for all study centres. Recruitment began in July 2021. Results will be published in international peer-reviewed medical journals.

Trial registration number: ClinicalTrials.gov NCT04408495.

Keywords: Cardiothoracic surgery; Mortality; Respiratory infections; Ventilators, Mechanical.

PubMed Disclaimer

Conflict of interest statement

Competing interests: AM received payments made to his institution from i-SEP for consulting fees, and from LFB, Aguettant, Viatris and Pfizer for lecture fees. BR received lecture fees from Laboratoire du Fractionnement et des Biotechnologies and Aspen, research grants from Aguettant and consulting fees from Laboratoire du Fractionnement et des Biotechnologies, Aguettant and Viatris. OA-A received lecture fees from Edwards Lifesciences. J-FO received lecture fees from Edwards Lifesciences. EB received lecture fees from LFB. Other authors declare no competing interests.

Figures

**Figure 1. Summary of the VACARM trial**

See this image and copyright information in PMC

References

1. Mathis MR, Duggal NM, Likosky DS, et al. Intraoperative mechanical ventilation and postoperative pulmonary complications after cardiac surgery. Anesthesiology. 2019;131:1046–62. doi: 10.1097/ALN.0000000000002909. - DOI - PMC - PubMed
1. Fischer M-O, Brotons F, Briant AR, et al. Postoperative pulmonary complications after cardiac surgery: the venice international cohort study. J Cardiothorac Vasc Anesth. 2022;36:2344–51. doi: 10.1053/j.jvca.2021.12.024. - DOI - PubMed
1. Young CC, Harris EM, Vacchiano C, et al. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019;123:898–913. doi: 10.1016/j.bja.2019.08.017. - DOI - PubMed
1. Futier E, Constantin J-M, Paugam-Burtz C, et al. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013;369:428–37. doi: 10.1056/NEJMoa1301082. - DOI - PubMed
1. Campos NS, Bluth T, Hemmes SNT, et al. Intraoperative positive end-expiratory pressure and postoperative pulmonary complications: a patient-level meta-analysis of three randomised clinical trials. Br J Anaesth. 2022;128:1040–51. doi: 10.1016/j.bja.2022.02.039. - DOI - PubMed

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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

Collaborators

Affiliations

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

Authors

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Affiliations

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Conflict of interest statement

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