دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial.
المؤلفون: Nguyen LS; Critical Care Medicine Department, CMC Ambroise Paré, 25-27 Boulevard Victor Hugo, 92200, Neuilly-sur-Seine, France. nguyen.lee@icloud.com., Merzoug M; Critical Care Medicine Department, CMC Ambroise Paré, 25-27 Boulevard Victor Hugo, 92200, Neuilly-sur-Seine, France., Estagnasie P; Critical Care Medicine Department, CMC Ambroise Paré, 25-27 Boulevard Victor Hugo, 92200, Neuilly-sur-Seine, France., Brusset A; Critical Care Medicine Department, CMC Ambroise Paré, 25-27 Boulevard Victor Hugo, 92200, Neuilly-sur-Seine, France., Law Koune JD; Anesthesiology Department, CMC Ambroise Paré, Neuilly-sur-Seine, France., Aubert S; Cardiac Surgery Department, CMC Ambroise Paré, Neuilly-sur-Seine, France., Waldmann T; Cardiac Surgery Department, CMC Ambroise Paré, Neuilly-sur-Seine, France., Grinda JM; Cardiac Surgery Department, CMC Ambroise Paré, Neuilly-sur-Seine, France., Gibert H; Anesthesiology Department, CMC Ambroise Paré, Neuilly-sur-Seine, France., Squara P; Critical Care Medicine Department, CMC Ambroise Paré, 25-27 Boulevard Victor Hugo, 92200, Neuilly-sur-Seine, France.
المصدر: Trials [Trials] 2017 Dec 02; Vol. 18 (1), pp. 582. Date of Electronic Publication: 2017 Dec 02.
نوع المنشور: Comparative Study; Journal Article; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Cardiac Surgical Procedures*/adverse effects , Cardiac Surgical Procedures*/economics , Cardiac Surgical Procedures*/mortality , Cardiopulmonary Bypass*/adverse effects , Cardiopulmonary Bypass*/economics , Cardiopulmonary Bypass*/mortality , Tidal Volume*, Lung/*physiopathology , Lung Diseases/*prevention & control , Respiration, Artificial/*methods, Clinical Protocols ; Double-Blind Method ; France ; Hospital Costs ; Hospital Mortality ; Humans ; Length of Stay ; Lung Diseases/economics ; Lung Diseases/etiology ; Lung Diseases/physiopathology ; Research Design ; Respiration, Artificial/adverse effects ; Respiration, Artificial/economics ; Respiration, Artificial/mortality ; Risk Factors ; Time Factors ; Treatment Outcome
مستخلص: 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.
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فهرسة مساهمة: Keywords: Cardiopulmonary bypass; Low tidal volume; Postoperative pulmonary complications; Protective ventilation
سلسلة جزيئية: ClinicalTrials.gov NCT03098524
تواريخ الأحداث: Date Created: 20171204 Date Completed: 20180716 Latest Revision: 20220331
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC5712097
DOI: 10.1186/s13063-017-2321-9
PMID: 29197407
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-017-2321-9