Effects of PERMISSive lung-protective ventilation on outcome in critically ill, invasively ventilated patients (PERMISS): protocol for a feasibility and safety randomised clinical trial.
Alessandro Caroli, Amarens Hoogenboom, Guillermo Bugedo, Felipe L Damiani, Juliana Ferreira, Marcelo Gama de Abreu, Jan-Willem Geerts, Bart P Grady, Stephanie S List, David M P van Meenen, Luis Morales-Quinteros, Frederique Paulus, Ary Serpa Neto, Marcus J Schultz, Arthur S Slutsky, Kanwalpreet Sodhi, Louise Urlings-Strop, Laura A Buiteman-Kruizinga
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Abstract
Introduction: Mechanical power (MP) of ventilation is a summary variable of determinants of ventilator-induced lung injury and is consistently associated with worse outcomes. Lung-protective ventilation (LPV) using a lower respiratory rate (RR) is an appealing strategy to reduce MP, but it is unclear whether reducing RR is feasible and safe in critically ill patients under invasive mechanical ventilation. Therefore, we test the hypothesis that a ventilation strategy that targets the lowest acceptable RR is feasible and safe.
Methods and analysis: The 'Effects of PERMISSive Lung-protective Ventilation on Outcome in Critically Ill, Invasively Ventilated Patients (PERMISS)' pilot study is an international, multicentre randomised clinical feasibility and safety trial in critically ill, invasively ventilated adult patients with an expected duration of ventilation >24 hours. Patients will be randomly assigned to 'permissive' LPV with a lower RR, within safety limits of arterial partial pressure of carbon dioxide (PaCO2) and pH, compared with conventional LPV with RR to target normal PaCO2 and pH. The primary endpoint is the difference in RR between the two groups from the start of ventilation until the first extubation. Secondary endpoints include safety, assessed by the incidence of unacceptable hypercapnia (PaCO2>70 mm Hg and pH<7.20), severe hypoxaemia (arterial partial pressure of oxygen (PaO2)<60 mm Hg), ventilator-associated complications and compliance with the protocol and quality of data collection.
Ethics and dissemination: The current version of the protocol is V.3 (issued on 11 December 2025). The trial was approved by the medical research ethics committee of Leiden Den Haag Delft (approval number NL-009624.P25.028) on 2 June 2025, including all amendments, and was registered on www.
Clinicaltrials: gov (NCT07077174). The PERMISS pilot is currently recruiting patients.
通气机械功率（MP）是呼吸机诱导肺损伤决定因素的一个总结变量，并且始终与较差的预后相关。采用低呼吸率（RR）进行肺保护性通气（LPV）是降低MP的一种有吸引力的策略，但对于有创机械通气危重患者降低RR是否可行和安全尚不清楚。因此，我们验证了以最低可接受RR为目标的通风策略是可行和安全的假设。方法与分析：“允许性肺保护性通气对危重患者有创通气（PERMISS）预后的影响”试点研究是一项国际多中心随机临床可行性和安全性试验，针对危重患者有创通气成人患者，预期通气持续时间为100 ~ 24小时。患者将被随机分配到具有较低RR的“允许”LPV，在动脉二氧化碳分压（PaCO2）和pH的安全范围内，与具有RR的常规LPV相比，目标是正常的PaCO2和pH。主要终点是两组之间从开始通气到第一次拔管的RR差异。次要终点包括安全性，通过不可接受的高碳酸血症（PaCO2>70 mm Hg和pH2）的发生率来评估。伦理和传播：目前版本的方案是V.3（于2025年12月11日发布）。该试验于2025年6月2日获得Leiden Den Den Haag Delft医学研究伦理委员会的批准（批准号NL-009624.P25.028），包括所有修订，并在www.Clinicaltrials: gov上注册（NCT07077174）。PERMISS试点项目目前正在招募患者。试验注册号：NCT07077174。
期刊介绍：
BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.
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