Mauri Tommaso, Foti Giuseppe, Fornari Carla, Constantin Jean-Michel, Guerin Claude, Pelosi Paolo, Ranieri Marco, Conti Sara, Tubiolo Daniela, Rondelli Egle, Lovisari Federica, Fossali Tommaso, Spadaro Savino, Grieco Domenico Luca, Navalesi Paolo, Calamai Italo, Becher Tobias, Roca Oriol, Wang Yu-Mei, Knafelj Rihard, Cortegiani Andrea, Mancebo Jordi, Brochard Laurent, Pesenti Antonio
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
ASST Monza, University of Milan-Bicocca, Monza, Italy.
Trials. 2018 Aug 29;19(1):460. doi: 10.1186/s13063-018-2828-8.
Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study).
PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and undergoing PSV from 4 to 24 h will be enrolled. All patients will first undergo a 30-min sigh test by adding sigh to clinical PSV for 30 min to identify early oxygenation responders. Then, patients will be randomized to PSV or PSV + sigh until extubation, ICU discharge, death or day 28. Sigh will be delivered as a 3-s pressure control breath delivered once per minute at 30 cmHO. Standardized protocols will guide ventilation settings, switch back to controlled ventilation, use of rescue treatments, performance of spontaneous breathing trial, extubation and reintubation. The primary endpoint of the study will be to verify the feasibility of PSV + sigh evaluated through reduction of failure to remain on assisted ventilation during the first 28 days in the PSV + sigh group versus standard PSV (15 vs. 22%). Failure will be defined by switch back to controlled ventilation for more than 24 h or use of rescue treatments or reintubation within 48 h from elective extubation. Setting the power to 80% and first-risk order to 5%, the computed size of the trial is 129 patients per arm.
PROTECTION is a pilot randomized controlled trial testing the feasibility of adding sigh to PSV. If positive, it will provide physicians with an effective addition to standard PSV for lung protection, able to reduce failure of assisted ventilation. PROTECTION will provide the basis for a future larger trial aimed at verifying the impact of PSV + sigh on 28-day survival and ventilator-free days.
ClinicalTrials.gov, NCT03201263 . Registered on 28 June 2017.
在辅助通气中添加周期性短时间持续膨胀（叹息）可优化肺复张，减少异质性，并降低急性低氧性呼吸衰竭（AHRF）患者的吸气努力。这些发现表明，在压力支持通气（PSV）中添加叹息可能会降低肺损伤风险，缩短撤机时间并改善临床结局。因此，我们构思了一项试点试验，以测试在PSV中添加叹息的可行性（PROTECTION研究）。
PROTECTION是一项国际随机对照试验，将在23个重症监护病房（ICU）中进行。纳入已插管24小时至7天且接受PSV治疗4至24小时的AHRF患者。所有患者将首先通过在临床PSV中添加叹息30分钟进行30分钟的叹息试验，以识别早期氧合反应者。然后，患者将被随机分为接受PSV或PSV +叹息治疗，直至拔管、ICU出院、死亡或第28天。叹息将作为一次3秒的压力控制呼吸，以30 cmH₂O的压力每分钟输送一次。标准化方案将指导通气设置、切换回控制通气、使用抢救治疗、进行自主呼吸试验、拔管和重新插管。该研究的主要终点将是通过降低PSV +叹息组与标准PSV组在最初28天内无法维持辅助通气的比例（15%对22%）来验证PSV +叹息的可行性。失败将定义为在择期拔管后48小时内切换回控制通气超过24小时、使用抢救治疗或重新插管。设定检验效能为80%，第一类错误概率为5%，计算得出每组试验规模为129例患者。
PROTECTION是一项试点随机对照试验，测试在PSV中添加叹息的可行性。如果结果为阳性，它将为医生提供一种有效的标准PSV辅助措施，用于肺保护，能够减少辅助通气失败。PROTECTION将为未来一项更大规模的试验提供基础，该试验旨在验证PSV +叹息对28天生存率和无呼吸机天数的影响。
ClinicalTrials.gov，NCT03201263。于2017年6月28日注册。
