Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE Critical Care and Resuscitation Pub Date : 2023-09-01 DOI:10.1016/j.ccrj.2023.06.007

Paul J. Young MBChB, PhD , Carol L. Hodgson PT, MPhil, PhD , Diane Mackle MN, PhD , Anne M. Mather BBiomed (Hons) , Richard Beasley MBChB, DSc , Rinaldo Bellomo MD , Stephen Bernard MD , Kathy Brickell RGN , Adam M. Deane PhD , Glenn Eastwood PhD , Simon Finfer MD , Alisa M. Higgins MPH, PhD , Anna Hunt BN , Cassie Lawrence BN , Natalie J. Linke BN , Edward Litton MD, PhD , Christine F. McDonald MBBS (Hons), PhD , James Moore MBChB, MSc , Alistair D. Nichol PhD , Shaanti Olatunji MClinImm , Jessica Kasza PhD

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引用次数: 1

Abstract

Background

The effect of conservative vs. liberal oxygen therapy on outcomes of intensive care unit (ICU) patients with hypoxic ischaemic encephalopathy (HIE) is uncertain and will be evaluated in the Low Oxygen Intervention for Cardiac Arrest injury Limitation (LOGICAL) trial.

Objective

The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial.

Design, setting, and participants

LOGICAL is a randomised clinical trial in adults in the ICU who are comatose with suspected HIE (i.e., those who have not obeyed commands following return of spontaneous circulation after a cardiac arrest where there is clinical concern about possible brain damage). The LOGICAL trial will include 1400 participants and is being conducted as a substudy of the Mega Randomised registry trial comparing conservative vs. liberal oxygenation targets in adults receiving unplanned invasive mechanical ventilation in the ICU (Mega-ROX).

Main outcome measures

The primary outcome is survival with favourable neurological function at 180 days after randomisation as measured with the Extended Glasgow Outcome Scale (GOS-E). A favourable neurological outcome will be defined as a GOS-E score of lower moderate disability or better (i.e. a GOS-E score of 5–8). Secondary outcomes include survival time, day 180 mortality, duration of invasive mechanical ventilation, ICU length of stay, hospital length of stay, the proportion of patients discharged home, quality of life assessed at day 180 using the EQ-5D-5L, and cognitive function assessed at day 180 using the Montreal Cognitive Assessment (MoCA-blind).

Conclusions

The LOGICAL trial will provide reliable data on the impact of conservative vs. liberal oxygen therapy in ICU patients with suspected HIE following resuscitation from a cardiac arrest. Prepublication of the LOGICAL protocol and statistical analysis plan prior to trial conclusion will reduce the potential for outcome-reporting or analysis bias.

Trial registration

Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).

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低氧介入治疗心脏骤停损伤限制(LOGICAL)试验的方案总结和统计分析计划

背景:保守氧疗与自由氧疗对重症监护病房(ICU)缺氧缺血性脑病(HIE)患者预后的影响尚不确定，将在低氧干预心脏骤停损伤限制(LOGICAL)试验中进行评估。目的总结logic试验的方案和统计分析方案。设计、环境和参与者:logic是一项随机临床试验，对象为ICU中疑似HIE的昏迷成人(即，在心脏骤停后恢复自发循环后不服从命令的患者，临床担心可能出现脑损伤)。logic试验将包括1400名参与者，作为Mega随机注册试验的一项子研究，比较在ICU接受无计划有创机械通气(Mega- rox)的成人中保守和自由氧合目标。主要结局指标主要结局指标是随机分组后180天具有良好神经功能的生存，用扩展格拉斯哥结局量表(GOS-E)测量。良好的神经预后将被定义为GOS-E评分为较低的中度残疾或更高(即GOS-E评分为5-8)。次要结局包括生存时间、180天死亡率、有创机械通气持续时间、ICU住院时间、住院时间、出院回家的患者比例、180天使用EQ-5D-5L评估的生活质量，以及180天使用蒙特利尔认知评估(moca盲法)评估的认知功能。结论:logic试验将为ICU患者心脏骤停复苏后疑似HIE患者保守氧疗与自由氧疗的影响提供可靠数据。在试验结论之前预先发表逻辑方案和统计分析计划将减少结果报告或分析偏倚的可能性。试验注册澳大利亚和新西兰临床试验注册中心(ACTRN12621000518864)。

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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.