Department of Anaesthesiology and Critical Care Medicine B, University Hospital Centre Montpellier, Montpellier, France.
Department of critical care patient acquired muscle weakness, INSERM U1046, Montpellier, France.
BMJ Open. 2023 Jul 12;13(7):e070931. doi: 10.1136/bmjopen-2022-070931.
Readiness to be freed from ventilatory support can be evaluated by spontaneous breathing trial (SBT) assessing the patient's ability to sustain respiratory effort after extubation. Current SBT practices are heterogenous and there are few physiological studies on the topic. The objective of this study is to assess which SBT best reproduces inspiratory effort to breathe after extubation depending on the patient's illness.
This will be a multicentre randomised cross-over physiological study, in a large population, in the era of modern intensive care units using last generation modern ventilators. Each included patient will perform three 15-minute SBTs in a random order: pressure support ventilation (PSV) level of 7 cmHO with positive end expiratory pressure (PEEP) level of 0 cmHO, PSV 0 cmHO with PEEP 0 cmHO and T-piece trial. A rest period of baseline state ventilation will be observed between the SBTs (10 min) and before extubation (30 min). Primary outcome will be the inspiratory muscle effort, reflected by pressure time product per minute (PTPmin). This will be calculated from oesophageal pressure measurements at baseline state, before and after each SBT and 20 min after extubation. Secondary outcomes will be PTPmin at 24 hours and 48 hours after extubation, changes in physiological variables and respiratory parameters at each step, postextubation respiratory management and the rate of successful extubation. One hundred patients with at least 24 hours of invasive mechanical ventilation will be analysed, divided into five categories of critical illness: abdominal surgery, brain injury, chest trauma, chronic obstructive pulmonary disease and miscellaneous (pneumonia, sepsis, heart disease).
The study project was approved by the appropriate ethics committee (2019-A01063-54, Comité de Protection des Personnes TOURS - Région Centre - Ouest 1, France). Informed consent is required, for all patients or surrogate in case of inability to give consent.
NCT04222569.
通过评估患者拔管后维持呼吸努力的能力的自主呼吸试验 (SBT)，可以评估脱离通气支持的准备情况。目前的 SBT 实践存在异质性，并且关于该主题的生理学研究很少。本研究的目的是评估根据患者的疾病，哪种 SBT 最能再现拔管后吸气努力呼吸。
这将是一项在现代重症监护病房中使用最新一代现代呼吸机的多中心随机交叉生理学研究，涉及大量患者。每个纳入的患者将以随机顺序进行三次 15 分钟的 SBT：压力支持通气 (PSV) 水平为 7 cmHO，呼气末正压 (PEEP) 水平为 0 cmHO，PSV 为 0 cmHO，PEEP 为 0 cmHO 和 T 型管试验。SBT 之间（10 分钟）和拔管前（30 分钟）将观察到基线通气的休息期。主要结局将是吸气肌努力，反映为每分钟压力时间乘积 (PTPmin)。这将从基线状态、每次 SBT 前后和拔管后 20 分钟的食管压力测量中计算得出。次要结局将是拔管后 24 小时和 48 小时的 PTPmin、每个步骤的生理变量和呼吸参数的变化、拔管后的呼吸管理以及成功拔管的比率。将分析至少有 24 小时有创机械通气的 100 名患者，分为五类危重病：腹部手术、脑损伤、胸部创伤、慢性阻塞性肺疾病和杂项（肺炎、脓毒症、心脏病）。
该研究项目已获得适当的伦理委员会批准（2019-A01063-54，法国 Tours-地区中心-西部 1 区保护人员委员会）。所有患者或无法同意的代理人都需要同意。
NCT04222569。
