Sigh Ventilation in Cardiac Surgery

Официальное название

Effect of Sigh Ventilation on Postoperative Pulmonary Complications in Cardiac Surgery: A Multicenter, Randomized Controlled Trial

Обзор

The purpose of this trial is to investigate whether sigh ventilation strategy, combining sigh breaths, low tidal volume, and moderate PEEP levels, protects against major pulmonary complications within the first 7 postoperative days after cardiac surgery, as compared with conventional ventilation strategy with low tidal volume, and moderate PEEP levels.

Подробное описание

Preventing postoperative pulmonary complications with the use of low tidal volume ventilation is now an established consensus. However, low tidal volume promote alveolar collapse in poorly ventilated, dependent regions of the lung.

Recruitment maneuvers, typically delivered at specific intraoperative timepoints, aimed to counteract alveolar collapse promoted by low tidal volume, was found to yield transient physiological benefits. And the PROVECS trial failed to show extra benefit of recruitment maneuvers in cardiac surgery patients in terms of pulmonary complications within the first 7 postoperative days, as compared with low tidal volume ventilation.

Sigh breaths, which involves cyclic deep inflations to re-expand alveoli, potentially providing sustained benefits. The purpose of this trial is to investigate the specific role of sigh breaths for reducing pulmonary complications in cardiac surgery patients already receiving protective ventilation with low tidal volume and moderate PEEP levels.

Вмешательства

• Другое Sigh Breaths
  Sigh breaths were added by elevating PEEP, targeting a plateau pressure of 35 cmH2O (or 40 cmH2O for patients with a Body Mass Index \> 35 kg/m2). These sigh breaths were administered once every 6 minutes at predefined stages in the perioperative period from the time of anesthesia intubation until endotracheal extubation, postoperative day 7, or death, whichever occurred first, but not during transport. Each sigh consisted of the minimum number of respiratory cycles aimed to achieve a total dura
• Другое Low Tidal Volume
  6-8ml/kg predicted body weight
• Другое Moderate PEEP
  PEEP set according to ARDSnet low PEEP- fraction of inspired oxygen table, FiO2 was set as the lowest fraction targeted to maintain SpO2 ≥ 96%

Первичные конечные точки

• Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through POD7 [Срок оценки: From randomization to postoperative day 7]

Вторичные конечные точки (9)

• Severity of postoperative pulmonary complications through POD7 [Срок оценки: From randomization to postoperative day 7]
• Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through hospitalization [Срок оценки: From randomization up to hospital discharge, assessed up to postoperative day 30]
• Severity of postoperative pulmonary complications through hospitalization [Срок оценки: From randomization up to hospital discharge, assessed up to postoperative day 30]
• No Ventilatory Support Days by POD7 [Срок оценки: From randomization to postoperative day 7]
• No Ventilatory Support Days by POD30 [Срок оценки: From randomization to postoperative day 30]
• Proportion of Acute Respiratory Distress Syndrome through hospitalization [Срок оценки: From randomization up to hospital discharge, assessed up to postoperative day 30]
• Intensive Care Unit length of stay by POD30 [Срок оценки: From randomization to postoperative day 30]
• Hospital length of stay by POD30 [Срок оценки: From randomization to postoperative day 30]
• 30-day mortality [Срок оценки: From randomization to postoperative day 30]

Критерии участия

Критерии включения

• 18 years of age or older;
• Elective cardiac surgery with cardiopulmonary bypass, aortic clamp and cardioplegia;
• Written informed consent is obtained from patients and/or their legal representatives.

Критерии исключения

• Emergence surgery;
• Left ventricular assist device implantation;
• Planned thoracotomy with one lung ventilation;
• Undergo concurrent surgical procedures outside cardiology;
• Neuromuscular illness;
• Mechanical ventilation within the last 2 weeks before surgery, include CPAP and NIV;
• Preoperative shock;
• Preoperative Hypoxemia (PaO2<60mmHg OR SpO2<90% on ambient air);
• Preoperative left ventricular ejection fraction < 40%;
• Systolic pulmonary artery pressure > 50 mmHg.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Zhongda Hospital, Southeast University — Нанкин

Публикации

• Lagier D, Velly LJ, Guinard B, Bruder N, Guidon C, Vidal Melo MF, Alessi MC. Perioperative Open-lung Approach, Regional Ventilation, and Lung Injury in Cardiac Surgery. Anesthesiology. 2020 Nov 1;133(5):1029-1045. doi: 10.1097/ALN.0000000000003539. PMID 32902561
• Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmo PMID 31576435

Идентификаторы

NCT: NCT07024420 · SIVECS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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