Protocol and statistical analysis plan for the identification and treatment of hypoxemic respiratory failure and acute respiratory distress syndrome with protection, paralysis, and proning: A type-1 hybrid stepped-wedge cluster randomised effectiveness-implementation study

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation Pub Date : 2023-12-01 DOI:10.1016/j.ccrj.2023.10.008

Ken Kuljit S. Parhar MD, MSc , Andrea Soo PhD , Gwen Knight BA , Kirsten Fiest PhD , Daniel J. Niven MD MSc PhD , Gordon Rubenfeld MD, MSc , Damon Scales MD, PhD , Henry T. Stelfox MD, PhD , Danny J. Zuege MD MSc , Sean Bagshaw MD, MSc

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引用次数: 0

Abstract

Objective

To describe a study protocol and statistical analysis plan (SAP) for the identification and treatment of hypoxemic respiratory failure (HRF) and acute respiratory distress syndrome (ARDS) with protection, paralysis, and proning (TheraPPP) study prior to completion of recruitment, electronic data retrieval, and analysis of any data.

Design

TheraPPP is a stepped-wedge cluster randomised study evaluating a care pathway for HRF and ARDS patients. This is a type-1 hybrid effectiveness-implementation study design evaluating both intervention effectiveness and implementation; however primarily powered for the effectiveness outcome.

Setting

Seventeen adult intensive care units (ICUs) across Alberta, Canada.

Participants

We estimate a sample size of 18816 mechanically ventilated patients, with 11424 patients preimplementation and 7392 patients postimplementation. We estimate 2688 sustained ARDS patients within our study cohort.

Intervention

An evidence-based, stakeholder-informed, multidisciplinary care pathway called Venting Wisely that standardises diagnosis and treatment of HRF and ARDS patients.

Main outcome measures

The primary outcome is 28-day ventilator-free days (VFDs). The primary analysis will compare the mean 28-day VFDs preimplementation and postimplementation using a mixed-effects linear regression model. Prespecified subgroups include sex, age, HRF, ARDS, COVID-19, cardiac surgery, body mass index, height, illness acuity, and ICU volume.

Results

This protocol and SAP are reported using the Standard Protocol Items: Recommendations for Interventional Trials guidance and the Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. The study received ethics approval and was registered (ClinicalTrials.gov-NCT04744298) prior to patient enrolment.

Conclusions

TheraPPP will evaluate the effectiveness and implementation of an HRF and ARDS care pathway.

查看原文本刊更多论文

通过保护、瘫痪和俯卧来识别和治疗低氧性呼吸衰竭和急性呼吸窘迫综合征的方案和统计分析计划：1型混合阶梯式楔形群随机有效性实施研究

目的在完成招募、电子数据检索和任何数据分析之前，描述低氧性呼吸衰竭（HRF）和急性呼吸窘迫综合征（ARDS）的识别和治疗与保护、瘫痪和俯卧位（TheraPPP）研究的研究方案和统计分析计划（SAP）。这是一项 1 型有效性-实施性混合研究设计，同时评估干预效果和实施情况；但主要针对有效性结果。我们估计研究队列中有 2688 名持续的 ARDS 患者。干预以证据为基础、由利益相关者提供信息的多学科护理路径，称为 "明智通气"（Venting Wisely），该路径对 HRF 和 ARDS 患者的诊断和治疗进行了标准化。主要分析将使用混合效应线性回归模型比较实施前和实施后的 28 天平均无呼吸机天数。预设亚组包括性别、年龄、HRF、ARDS、COVID-19、心脏手术、体重指数、身高、疾病敏锐度和 ICU 容量：本方案和 SAP 采用《标准方案项目：介入性试验指南建议》和《临床试验统计分析计划内容指南》进行报告。结论TheraPPP将评估HRF和ARDS护理路径的有效性和实施情况。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Critical Care and Resuscitation CRITICAL CARE MEDICINE-

CiteScore

7.70

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines. The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world. The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.