Department of Critical Care Medicine, Beijing Tiantan Hospital, Beijing, China.
Beijing Shijitan Hospital Capital Medical University, Beijing, China.
BMJ Open. 2024 Aug 3;14(8):e082395. doi: 10.1136/bmjopen-2023-082395.
Although pressure support ventilation is one of the most commonly used assisted ventilation modes in intensive care units, there is still a lack of precise strategies for setting pressure support. By performing an end-inspiratory airway occlusion, the difference between the peak and plateau airway pressure, which is defined as pressure muscle index (PMI), can be easily measured on the ventilator screen. Previous studies have shown that PMI is accurate in detecting high and low inspiratory effort. No study has been conducted to investigate the use of PMI as an indicator for setting inspiratory pressure support.
This is a study protocol for a prospective, single-centre, randomised controlled, pilot trial. Sixty participants undergoing pressure support ventilation will be randomly assigned in a 1:1 ratio to the control group or intervention group, with pressure support adjusted according to standard care or guided by the PMI strategy for 48 hours, respectively. The feasibility of the PMI-guided strategy will be evaluated. The primary endpoint is the proportion of inspiratory effort measurements within a well-accepted 'normal' range, which is predefined as oesophageal pressure-time product per minute between 50 and 200 cmHO⋅s/min, for each patient during 48 hours of pressure support adjustment.
The study protocol has been approved by Beijing Tiantan Hospital (KY2023-005-02). The data generated in the present study will be available from the corresponding author on reasonable request. The results of the trial will be submitted to international peer-reviewed journals.
NCT05963737; ClinicalTrials.org.
尽管压力支持通气是重症监护病房最常用的辅助通气模式之一，但在设置压力支持方面仍缺乏精确的策略。通过进行吸气末气道阻塞，可以在呼吸机屏幕上轻松测量峰压和平台压之间的差值，即压力肌指数（PMI）。先前的研究表明，PMI 可以准确检测高和低吸气努力。尚未有研究探讨使用 PMI 作为设置吸气压力支持的指标。
这是一项前瞻性、单中心、随机对照、初步试验的研究方案。60 名正在接受压力支持通气的参与者将按照 1:1 的比例随机分配到对照组或干预组，分别根据标准护理或 PMI 策略调整压力支持 48 小时。将评估 PMI 指导策略的可行性。主要终点是在 48 小时压力支持调整期间，每位患者的食管压力-时间乘积每分钟（oesophageal pressure-time product per minute）在 50 至 200 cmHO ⋅ s/min 之间的可接受“正常”范围内的吸气努力测量比例。
本研究方案已获得北京天坛医院的批准（KY2023-005-02）。符合合理要求，可从通讯作者处获得本研究产生的数据。试验结果将提交给国际同行评议期刊。
NCT05963737；ClinicalTrials.org。
