METHODS: Sixty patients aged ≥ 18 years, with clinical diagnosis of acute stroke, confirmed by neuroimaging examination, with onset of symptoms within 72 h, under mechanical ventilation through tracheal tube, will participate in this study. Participants will be randomly allocated into 2 groups: experimental group (n = 30)-MHM plus tracheal aspiration-and control group (n = 30)-tracheal aspiration only. Intracranial compliance will be measured by a non-invasive technique using Brain4care BcMM-R-2000 sensor. This will be the primary outcome. Results will be recorded at 5 times: T0 (start of monitoring), T1 (moment before MHM), T2 (moment after the MHM and before tracheal aspiration), T3 (moment after tracheal aspiration), T4, and T5 (monitoring 10 and 20 min after T3). Secondary outcomes are respiratory mechanics and hemodynamic parameters.
CONCLUSIONS: This study will be the first clinical trial to examine the effects and safety of MHM on intracranial compliance measured by non-invasive monitoring. Limitation includes the impossibility of blinding the physical therapist who will supervise the interventions. It is expected with this study to demonstrate that MHM can improve respiratory mechanics and hemodynamic parameters and provide a safe intervention with no changes in intracranial compliance in stroke patients.
方法:60名年龄≥18岁的患者,急性中风的临床诊断,通过神经影像学检查证实,在72小时内出现症状,在通过气管导管机械通气的情况下,将参与这项研究。参与者将被随机分为2组:实验组(n=30)-MHM加气管抽吸和对照组(n=30)-仅气管抽吸。颅内顺应性将通过使用Brain4careBcMM-R-2000传感器的非侵入性技术来测量。这将是主要结果。结果将在5次记录:T0(开始监测),T1(MHM之前的时刻),T2(MHM之后和气管抽吸之前的时刻),T3(气管抽吸后瞬间),T4和T5(T3后10和20分钟监测)。次要结果是呼吸力学和血液动力学参数。
结论:这项研究将是第一个临床试验,旨在通过无创监测来检查MHM对颅内顺应性的影响和安全性。限制包括不可能使监督干预措施的物理治疗师蒙蔽。这项研究有望证明MHM可以改善呼吸力学和血液动力学参数,并提供安全的干预措施,而卒中患者的颅内顺应性没有变化。