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.
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。