关键词: Adult intensive & critical care Clinical Trial Respiratory Therapy

Mesh : Humans Prospective Studies Pilot Projects Respiratory Muscles / physiology Proof of Concept Study Positive-Pressure Respiration / methods Respiration, Artificial / methods Randomized Controlled Trials as Topic Intensive Care Units

来  源:   DOI:10.1136/bmjopen-2023-082395   PDF(Pubmed)

Abstract:
BACKGROUND: 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.
METHODS: 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 cmH2O⋅s/min, for each patient during 48 hours of pressure support adjustment.
BACKGROUND: 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.
BACKGROUND: NCT05963737; ClinicalTrials.org.
摘要:
背景:尽管压力支持通气是重症监护病房中最常用的辅助通气模式之一,仍然缺乏设定压力支持的精确策略。通过执行吸气末气道阻塞,峰值和高原气道压力之间的差异,定义为压力肌指数(PMI),可以在呼吸机屏幕上轻松测量。先前的研究表明,PMI在检测高吸气量和低吸气量方面是准确的。尚未进行研究以调查使用PMI作为设定吸气压力支持的指标。
方法:这是一个前瞻性的研究方案,单中心,随机对照,试点试验。60名接受压力支持通气的参与者将以1:1的比例随机分配到对照组或干预组。根据标准护理调整压力支持或由PMI策略指导48小时,分别。将评估PMI指导战略的可行性。主要终点是公认的正常范围内的吸气努力测量值的比例,预定义为每分钟50至200cmH2O·s/min之间的食管压力-时间乘积,在48小时的压力支持调整期间,每位患者。
背景:研究方案已获得北京天坛医院批准(KY2023-005-02)。本研究中产生的数据将根据合理要求从相应的作者处获得。试验结果将提交给国际同行评审期刊。
背景:NCT05963737;ClinicalTrials.org。
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