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“开始活动”方案对功能、ICU 获得性肌无力和谵妄的疗效:一项随机临床试验。

Efficacy of the "Start to move" protocol on functionality, ICU-acquired weakness and delirium: A randomized clinical trial.

机构信息

Unidad del Paciente Crítico, Hospital Félix Bulnes, Cerro Navia, Santiago, Chile.

Equipo de Terapia Respiratoria, Hospital Clínico Red Salud Christus-UC, Chile; Exercise and Rehabilitation Sciences Institute, Faculty of Rehabilitation Sciences, Universidad Andrés Bello, Santiago, Chile.

出版信息

Med Intensiva (Engl Ed). 2024 Apr;48(4):211-219. doi: 10.1016/j.medine.2024.01.003. Epub 2024 Feb 23.

Abstract

OBJECTIVE

To evaluate the efficacy of the Start to move protocol compared to conventional treatment in subjects over 15 years of age hospitalized in the ICU on an improvement in functionality, decrease in ICU-acquired weakness (DAUCI), incidence of delirium, days of mechanical ventilation (MV), length of stay in ICU and mortality at 28 days.

DESIGN

randomized controlled clinical trial.

SETTING

Intensive Care Unit.

PARTICIPANTS

Includes adults older than 15 years with invasive mechanical ventilation more than 48h, randomized allocation.

INTERVENTIONS

Start to move protocol and conventional treatment.

MAIN VARIABLES OF INTEREST

Functionality, incidence of ICU-acquired weakness, incidence of delirium, days on mechanical ventilation, ICU stay and mortality-28 days, ClinicalTrials.gov number, NCT05053724.

RESULTS

69 subjects were admitted to the study, 33 to the Start to move group and 36 to conventional treatment, clinically and sociodemographic comparable. In the "Start to move" group, the incidence of IUCD at ICU discharge was 35.7% vs. 80.7% in the "conventional treatment" group (p=0.001). Functionality (FSS-ICU) at ICU discharge corresponds to 26 vs. 17 points in favor of the "Start to move" group (p=0.001). The difference in Barthel at ICU discharge was 20% in favor of the "Start to move" group (p=0.006). There were no significant differences in the incidence of delirium, days of mechanical ventilation, ICU stay and 28-day mortality. The study did not report adverse events or protocol suspension.

CONCLUSIONS

The application of the "Start to move" protocol in ICU showed a reduction in the incidence of IUAD, an increase in functionality and a smaller decrease in Barthel score at discharge.

摘要

目的

评估 Start to move 方案相较于常规治疗,对 ICU 住院超过 15 岁的患者在改善功能、减少 ICU 获得性肌无力(DAUCI)、谵妄发生率、机械通气天数(MV)、ICU 住院天数和 28 天死亡率方面的疗效。

设计

随机对照临床试验。

设置

重症监护病房。

参与者

纳入年龄大于 15 岁、有超过 48 小时的有创机械通气、随机分组的成年患者。

干预措施

Start to move 方案和常规治疗。

主要观察变量

功能、ICU 获得性肌无力发生率、谵妄发生率、机械通气天数、ICU 住院天数和 28 天死亡率,临床试验注册号:NCT05053724。

结果

69 名患者纳入研究,33 名进入 Start to move 组,36 名进入常规治疗组,临床和社会人口统计学特征相似。在“Start to move”组,ICU 出院时 ICU 获得性肌无力的发生率为 35.7%,而在“常规治疗”组为 80.7%(p=0.001)。ICU 出院时的功能(FSS-ICU)评分分别为 26 分和 17 分,“Start to move”组更优(p=0.001)。ICU 出院时的巴氏量表评分差异为 20%,“Start to move”组更优(p=0.006)。谵妄发生率、机械通气天数、ICU 住院天数和 28 天死亡率无显著差异。该研究未报告不良事件或方案暂停。

结论

在 ICU 中应用“Start to move”方案可降低 ICU 获得性肌无力的发生率,提高功能,减少出院时巴氏量表评分的下降。

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