多方面早期活动干预对危重症儿童的影响 - PICU Up! 试验：一项多中心阶梯式楔形集群随机对照试验的研究方案。

Impact of a multifaceted early mobility intervention for critically ill children - the PICU Up! trial: study protocol for a multicenter stepped-wedge cluster randomized controlled trial.

机构信息

Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

"George Emil Palade" University of Medicine, Pharmacy, Science, and Technology, Targu Mures, Romania.

出版信息

Trials. 2023 Mar 15;24(1):191. doi: 10.1186/s13063-023-07206-2.

DOI:10.1186/s13063-023-07206-2

PMID:36918956

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10015670/

Abstract

BACKGROUND

Over 50% of all critically ill children develop preventable intensive care unit-acquired morbidity. Early and progressive mobility is associated with improved outcomes in critically ill adults including shortened duration of mechanical ventilation and improved muscle strength. However, the clinical effectiveness of early and progressive mobility in the pediatric intensive care unit has never been rigorously studied. The objective of the study is to evaluate if the PICU Up! intervention, delivered in real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children. Additionally, the study aims to identify factors associated with reliable PICU Up! delivery.

METHODS

The PICU Up! trial is a stepped-wedge, cluster-randomized trial of a pragmatic, interprofessional, and multifaceted early mobility intervention (PICU Up!) conducted in 10 pediatric intensive care units (PICUs). The trial's primary outcome is days alive free of mechanical ventilation (through day 21). Secondary outcomes include days alive and delirium- and coma-free (ADCF), days alive and coma-free (ACF), days alive, as well as functional status at the earlier of PICU discharge or day 21. Over a 2-year period, data will be collected on 1,440 PICU patients. The study includes an embedded process evaluation to identify factors associated with reliable PICU Up! delivery.

DISCUSSION

This study will examine whether a multifaceted strategy to optimize early mobility affects the duration of mechanical ventilation, delirium incidence, and functional outcomes in critically ill children. This study will provide new and important evidence on ways to optimize short and long-term outcomes for pediatric patients.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04989790. Registered on August 4, 2021.

摘要

背景

超过 50%的重症患儿会在重症监护病房中患上可预防的并发症。在重症成人患者中，早期且逐渐增加的活动与改善预后相关，包括缩短机械通气时间和增强肌肉力量。然而，在儿科重症监护病房中开展早期且逐渐增加的活动的临床效果从未得到过严格的研究。本研究旨在评估 PICU Up! 干预措施（在真实环境中实施）是否能减少机械通气时间（主要结局），并与重症患儿的常规护理相比，改善谵妄和功能状态。此外，本研究旨在确定与可靠实施 PICU Up! 相关的因素。

方法

PICU Up! 试验是一项在 10 个儿科重症监护病房（PICU）中开展的、实用的、多专业和多方面的早期活动干预（PICU Up!）的阶梯式、整群随机试验。该试验的主要结局是无机械通气存活天数（至第 21 天）。次要结局包括无机械通气、谵妄和昏迷天数（ADCF）、无机械通气和昏迷天数（ACF）、无机械通气天数，以及在 PICU 出院或第 21 天较早时的功能状态。在 2 年期间，将对 1440 名 PICU 患儿进行数据收集。该研究包括一个嵌入式的过程评估，以确定与可靠实施 PICU Up! 相关的因素。