Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial

Lee S Nguyen, Messaouda Merzoug, Philippe Estagnasie, Alain Brusset, Jean-Dominique Law Koune, Stephane Aubert, Thierry Waldmann, Jean-Michel Grinda, Hadrien Gibert, Pierre Squara, Lee S Nguyen, Messaouda Merzoug, Philippe Estagnasie, Alain Brusset, Jean-Dominique Law Koune, Stephane Aubert, Thierry Waldmann, Jean-Michel Grinda, Hadrien Gibert, Pierre Squara

Abstract

Background: Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) during surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain low tidal volume (LTV) ventilation. Indirect evidence points towards better pulmonary outcomes when LTV is performed but no large-scale prospective trial has yet been published in cardiac surgery.

Design: The MECANO trial is a single-center, double-blind, randomized, controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. In total, 1500 patients are expected to be included, without any restrictions. They will be randomized between noV and LTV on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 breaths/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. The primary endpoint will be a composite of all-cause mortality, early respiratory failure defined as a ratio of partial pressure of oxygen/fraction of inspired oxygen <200 mmHg at 1 hour after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either non-invasive ventilation, mechanical ventilation or high-flow oxygen) at 2 days after arrival in the ICU or ventilator-acquired pneumonia defined by the Center of Disease Control. Lung recruitment maneuvers will be performed in the noV and LTV groups at the end of surgery and at arrival in ICU with an insufflation at +30 cmH20 for 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cell transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge.

Discussion: The MECANO trial is the first of its kind to compare in a double-blind design, a no-ventilation to a low-tidal volume strategy for mechanical ventilation during cardiac surgery with CPB, with a primary composite outcome including death, respiratory failure and postoperative pneumonia.

Trial registration: ClinicalTrials.gov, NCT03098524 . Registered on 27 February 2017.

Keywords: Cardiopulmonary bypass; Low tidal volume; Postoperative pulmonary complications; Protective ventilation.

Conflict of interest statement

Authors’ information

All authors belong to CMC Ambroise Paré located in Neuilly-sur-Seine, France.

Ethics approval and consent to participate

Institutional Review Board (Comité de Protection des Personnes) approval: 22 November 2016 (Hopital de Bicêtre, 78 rue du général Leclerc, 94275 Le Kremlin Bicetre). Declared on ClinicalTrials.gov under NCT03098524. Every patient was clearly informed and was required to sign to consent before inclusion in the study.

Consent for publication

Approved by the co-authors.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design. CPB cardiopulmonary bypass; FiO2 fraction of inspired oxygen; ICU intensive care unit; LTV low-tidal volume; TV tidal volume; MV mechanical ventilation; noV no ventilation; PEEP positive end-expiratory pressure; IBW ideal body weight; I:E Inspiratory:Expiratory

References

    1. Canet J, Gallart L, Gomar C, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113:1338–50. doi: 10.1097/ALN.0b013e3181fc6e0a.
    1. Kollef MH. Ventilator-associated pneumonia. A multivariate analysis. JAMA. 1993;270:1965–70. doi: 10.1001/jama.1993.03510160083034.
    1. Kollef MH, Sharpless L, Vlasnik J, et al. The impact of nosocomial infections on patient outcomes following cardiac surgery. Chest. 1997;112:666–75. doi: 10.1378/chest.112.3.666.
    1. Allou N, Bronchard R, Guglielminotti J, et al. Risk factors for postoperative pneumonia after cardiac surgery and development of a preoperative risk score*. Crit Care Med. 2014;42:1150–6. doi: 10.1097/CCM.0000000000000143.
    1. Bouza E, Perez A, Munoz P, et al. Ventilator-associated pneumonia after heart surgery: a prospective analysis and the value of surveillance. Crit Care Med. 2003;31:1964–70. doi: 10.1097/01.ccm.0000084807.15352.93.
    1. Ibanez J, Riera M, Amezaga R, et al. Long-term mortality after pneumonia in cardiac surgery patients: a propensity-matched analysis. J Intensive Care Med. 2016;31:34–40. doi: 10.1177/0885066614523918.
    1. Passaroni AC, Silva MA, Yoshida WB. Cardiopulmonary bypass: development of John Gibbon’s heart-lung machine. Rev Bras Cir Cardiovasc. 2015;30:235–45.
    1. Loeckinger A, Kleinsasser A, Lindner KH, et al. Continuous positive airway pressure at 10 cm H(2)O during cardiopulmonary bypass improves postoperative gas exchange. Anesth Analg. 2000;91:522–7. doi: 10.1213/00000539-200009000-00004.
    1. Bignami E, Guarnieri M, Saglietti F, et al. Mechanical ventilation during cardiopulmonary bypass: a review. J Cardiothorac Vasc Anesth. 2016;30(6):1668–75. doi: 10.1053/j.jvca.2016.03.015.
    1. Ng CS, Arifi AA, Wan S, et al. Ventilation during cardiopulmonary bypass: impact on cytokine response and cardiopulmonary function. Ann Thorac Surg. 2008;85:154–62. doi: 10.1016/j.athoracsur.2007.07.068.
    1. Zupancich E, Paparella D, Turani F, et al. Mechanical ventilation affects inflammatory mediators in patients undergoing cardiopulmonary bypass for cardiac surgery: a randomized clinical trial. J Thorac Cardiovasc Surg. 2005;130:378–83. doi: 10.1016/j.jtcvs.2004.11.061.
    1. Coppola S, Froio S, Chiumello D. Protective lung ventilation during general anesthesia: is there any evidence? Crit Care. 2014;18:210. doi: 10.1186/cc13777.
    1. Bignami E, Guarnieri M, Saglietti F, et al. Different strategies for mechanical VENTilation during CardioPulmonary Bypass (CPBVENT 2014): study protocol for a randomized controlled trial. Trials. 2017;18:264. doi: 10.1186/s13063-017-2008-2.
    1. Centers for Disease Control and Prevention. Pneumonia (Ventilator associated [VAP] and non-ventilator-associated Pneumonia [PNEU]). 2017;6:1-17. .
    1. Futier E, Constantin JM, 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.
    1. Chi D, Chen C, Shi Y, et al. Ventilation during cardiopulmonary bypass for prevention of respiratory insufficiency: a meta-analysis of randomized controlled trials. Medicine. 2017;96:e 6454. doi: 10.1097/MD.0000000000006454.
    1. Kelkar KV. Post-operative pulmonary complications after non-cardiothoracic surgery. Indian J Anaesth. 2015;59:599–605. doi: 10.4103/0019-5049.165857.
    1. Romagnoli S, Ricci Z. Lung protective ventilation in Cardiac Surgery. Heart Lung Vessel. 2015;7:5–6.
    1. Zabeeda D, Gefen R, Medalion B, et al. The effect of high-frequency ventilation of the lungs on postbypass oxygenation: a comparison with other ventilation methods applied during cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2003;17:40–4. doi: 10.1053/jcan.2003.8.
    1. Claxton BA, Morgan P, McKeague H, et al. Alveolar recruitment strategy improves arterial oxygenation after cardiopulmonary bypass. Anaesthesia. 2003;58:111–6. doi: 10.1046/j.1365-2044.2003.02892.x.
    1. Ayad AE, Hamed HF. Continuous positive airway pressure (CPAP) during cardiopulmonary bypass attenuates postoperative pulmonary dysfunction and complications. Egypt J Anaesth. 2003;19:345–51.
    1. Figueiredo L, Araujo S, Abdala RC, et al. CPAP at 10 cm H2O during cardiopulmonary bypass does not improve postoperative gas exchange. Rev Bras Cir Cardiovasc. 2008;23(2):209–15. doi: 10.1590/S0102-76382008000200010.
    1. Bockeria LA, Zaharchenko A, Antonenko D, et al. A study assessing the potential benefit of continued ventilation during cardiopulmonary bypass. Interact Cardiovasc Thorac Surg. 2008;7:14–7. doi: 10.1510/icvts.2007.158451.
    1. Scherer M, Detmer DS, Meininger D, et al. Alveolar recruitment strategy during cardiopulmonary bypass does not improve postoperative gas exchange and lung function. Cardiovasc Eng. 2009;9:1–5. doi: 10.1007/s10558-009-9063-6.
    1. Davoudi M, Farhanchi A, Moradi A, et al. The effect of low tidal volume ventilation during cardiopulmonary bypass on postoperative pulmonary function. J Tehran Heart Cent. 2010;5:128–31.
    1. Beer L, Szerafin T, Mitterbauer A, et al. Continued mechanical ventilation during coronary artery bypass graft operation attenuates the systemic immune response. Eur J Cardiothorac Surg. 2013;44:282–7. doi: 10.1093/ejcts/ezs659.
    1. Beer L, Szerafin T, Mitterbauer A, et al. Low tidal volume ventilation during cardiopulmonary bypass reduces postoperative chemokine serum concentrations. Thorac Cardiovasc Surg. 2014;62:677–82. doi: 10.1055/s-0034-1387824.
    1. Beer L, Warszawska JM, Schenk P, Debreceni T, et al. Intraoperative ventilation strategy during cardiopulmonary bypass attenuates the release of matrix metalloproteinases and improves oxygenation. J Surg Res. 2015;195:294–302. doi: 10.1016/j.jss.2014.12.022.
    1. Durukan A, Salman N, Unal EU, et al. Ventilation during cardiopulmonary bypass did not attenuate inflammatory response or affect postoperative outcomes. Cardiovasc J Afr. 2013;24:224–30. doi: 10.5830/CVJA-2013-041.
    1. Gagnon J, Laporta D, Beique F, et al. Clinical relevance of ventilation during cardiopulmonary bypass in the prevention of postoperative lung dysfunction. Perfusion. 2010;25:205–10. doi: 10.1177/0267659110373839.
    1. Macedo FI, Costa AC, Pham SM, et al. Beating heart surgery with pulmonary perfusion and ventilation during cardiopulmonary bypass: target organs’ perfusion without plegia. Semin Thorac Cardiovasc Surg. 2012;24:308–10. doi: 10.1053/j.semtcvs.2012.08.002.

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