Jiangsu Provincial Key Laboratory of Critical Care Medicine, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China.
Department of Anesthesiology, Surgery and Pain Management, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China.
Trials. 2024 Sep 4;25(1):585. doi: 10.1186/s13063-024-08416-y.
Postoperative hypoxemia and pulmonary complications remain a frequent event after on-pump cardiac surgery and mostly characterized by pulmonary atelectasis. Surfactant dysfunction or hyposecretion happens prior to atelectasis formation, and sigh represents the strongest stimulus for surfactant secretion. The role of sigh breaths added to conventional lung protective ventilation in reducing postoperative hypoxemia and pulmonary complications among cardiac surgery is unknown.
The perioperative sigh ventilation in cardiac surgery (E-SIGHT) trial is a single-center, two-arm, randomized controlled trial. In total, 192 patients scheduled for elective cardiac surgery with cardiopulmonary bypass (CPB) and aortic cross-clamp will be randomized into one of the two treatment arms. In the experimental group, besides conventional lung protective ventilation, sigh volumes producing plateau pressures of 35 cmHO (or 40 cmHO for patients with body mass index > 35 kg/m) delivered once every 6 min from intubation to extubation. In the control group, conventional lung protective ventilation without preplanned recruitment maneuvers is used. Lung protective ventilation (LPV) consists of low tidal volumes (6-8 mL/kg of predicted body weight) and positive end-expiratory pressure (PEEP) setting according to low PEEP/FiO table for acute respiratory distress syndrome (ARDS). The primary endpoint is time-weighted average SpO/FiO ratio during the initial post-extubation hour. Main secondary endpoint is the severity of postoperative pulmonary complications (PPCs) computed by postoperative day 7.
The E-SIGHT trial will be the first randomized controlled trial to evaluate the impact of perioperative sigh ventilation on the postoperative outcomes after on-pump cardiac surgery. The trial will introduce and assess a novel perioperative ventilation approach to mitigate the risk of postoperative hypoxemia and PPCs in patients undergoing cardiac surgery. Also provide the basis for a future larger trial aiming at verifying the impact of sigh ventilation on postoperative pulmonary complications.
ClinicalTrials.gov NCT06248320. Registered on January 30, 2024. Last updated February 26, 2024.
体外循环心脏手术后仍常发生低氧血症和肺部并发症，其主要特征为肺不张。表面活性物质功能障碍或分泌不足先于不张形成，叹气代表表面活性物质分泌的最强刺激。在常规肺保护性通气的基础上增加叹气呼吸对降低心脏手术后低氧血症和肺部并发症的作用尚不清楚。
心脏手术围手术期叹气通气（E-SIGHT）试验是一项单中心、两臂、随机对照试验。共纳入 192 例行体外循环（CPB）和主动脉阻断的择期心脏手术患者，随机分为两组。实验组除常规肺保护性通气外，从气管插管到拔管，每 6 分钟给予一次产生平台压 35cmH2O（BMI＞35kg/m2 的患者为 40cmH2O）的叹气容积。对照组采用无计划复张手法的常规肺保护性通气。肺保护性通气（LPV）采用低潮气量（预测体重的 6-8ml/kg）和呼气末正压（PEEP），根据急性呼吸窘迫综合征（ARDS）的低 PEEP/FiO 表设置。主要终点是拔管后最初 1 小时的时间加权平均 SpO/FiO 比值。主要次要终点是术后第 7 天计算的术后肺部并发症（PPCs）的严重程度。
E-SIGHT 试验将是第一项评估体外循环心脏手术后围手术期叹气通气对术后结果影响的随机对照试验。该试验将引入并评估一种新的围手术期通气方法，以降低接受心脏手术的患者术后低氧血症和 PPCs 的风险。为进一步更大规模的试验提供了基础，旨在验证叹气通气对术后肺部并发症的影响。
ClinicalTrials.gov NCT06248320。注册于 2024 年 1 月 30 日。2024 年 2 月 26 日最后更新。
