清醒俯卧位持续时间对 COVID-19 急性呼吸衰竭患者插管或死亡率的影响：一项随机临床试验的二次分析
Impact of awake prone positioning duration on intubation or mortality in COVID-19 patients with acute respiratory failure: secondary analysis of a randomized clinical trial.
作者信息
Sun Qin, Zhang Rui, Zhang Junyi, Xie Jianfeng, Huang Yingzi, Yang Yi, Qiu Haibo, Liu Ling, Chen Hui
机构信息
Jiangsu Provincial Key Laboratory of Critical Care Medicine, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, 87 Dingjiaqiao Rd., Nanjing, 210009, People's Republic of China.
出版信息
Ann Intensive Care. 2025 Jun 23;15(1):84. doi: 10.1186/s13613-025-01501-8.
BACKGROUND
Compared with shorter awake prone positioning (APP), prolonged APP (≥ 12 h daily) reduces the intubation rate in patients with COVID-19-related acute hypoxemic respiratory failure (AHRF). However, the optimal APP duration is uncertain. In this secondary analysis, we aimed to explore whether a longer APP duration is associated with improved outcomes and to identify the optimal duration of APP.
METHODS
Data from a multicenter randomized controlled trial involving nonintubated COVID-19 patients with AHRF were analyzed. Daily APP duration over 7 days after randomization was recorded as the primary exposure in present study. The primary outcome was the time from randomization to APP failure, which was defined as a composite of tracheal intubation or mortality within 28 days. A Cox proportional hazards regression model was employed to elucidate the associations, and the daily duration of APP was treated as time dependent.
RESULTS
A total of 409 patients were randomized in the original trial, and 408 were enrolled in this analysis. Among these patients, 105 (25.7%) experienced APP failure. A longer daily APP duration was associated with a lower risk of APP failure, with a hazard ratio (HR) of 0.93 (95% confidence interval (CI): 0.88-0.98), and the association was significant only during the first three days after randomization. There was a nonlinear relationship between the daily APP duration and the risk of APP failure (P = 0.015 for nonlinearity). Compared with patients whose APP duration ranged from 8 to 12 h per day, patients with less than 8 h of APP per day had a greater risk of APP failure (HR 2.44, 95% CI 1.21-4.92), whereas extending APP beyond 12 h per day did not improve the outcomes further (HR 1.03, 95% CI 0.51-2.10, P = 0.932).
INTERPRETATION
A longer daily APP duration was associated with a reduced risk of APP failure in COVID-19-related AHRF patients, and the optimal APP duration was 8-12 h per day. Clinical trial ClinicalTrials.gov: NCT05677984, Registered January 3, 2023. https://register.
CLINICALTRIALS
gov/prs/app/action/SelectProtocol?sid=S000CST9&selectaction=Edit&uid=U0000YKY&ts=4&cx=-x0muek.
背景
与较短时间的清醒俯卧位通气（APP）相比，延长APP（每日≥12小时）可降低新型冠状病毒肺炎（COVID-19）相关急性低氧性呼吸衰竭（AHRF）患者的插管率。然而，最佳的APP持续时间尚不确定。在这项二次分析中，我们旨在探讨更长的APP持续时间是否与更好的预后相关，并确定APP的最佳持续时间。
方法
分析了一项多中心随机对照试验的数据，该试验纳入了非插管的COVID-19相关AHRF患者。随机分组后7天内的每日APP持续时间被记录为本研究的主要暴露因素。主要结局是从随机分组到APP失败的时间，APP失败定义为28天内气管插管或死亡的复合事件。采用Cox比例风险回归模型来阐明两者之间的关联，APP的每日持续时间被视为时间依赖性因素。
结果
在原始试验中共有409例患者被随机分组，本分析纳入了408例。在这些患者中，105例（25.7%）发生了APP失败。每日APP持续时间越长，APP失败风险越低，风险比（HR）为0.93（95%置信区间（CI）：0.88 - 0.98），且该关联仅在随机分组后的前三天具有统计学意义。每日APP持续时间与APP失败风险之间存在非线性关系（非线性检验P = 0.015）。与每日APP持续时间为8至12小时的患者相比，每日APP持续时间少于8小时的患者发生APP失败的风险更高（HR 2.44，95% CI 1.21 - 4.92），而将APP延长至每日超过12小时并不能进一步改善预后（HR 1.03，95% CI 0.51 - 2.10，P = 0.932）。
解读
在COVID-19相关AHRF患者中，每日更长时间的APP持续时间与降低APP失败风险相关，最佳APP持续时间为每日8至12小时。临床试验ClinicalTrials.gov：NCT05677984，于2023年1月3日注册。https://register.
CLINICALTRIALS
gov/prs/app/action/SelectProtocol?sid=S000CST9&selectaction=Edit&uid=U
Zotero 插件