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
{"title":"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","authors":"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","doi":"10.1016/j.ccrj.2023.06.007","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial.</p></div><div><h3>Design, setting, and participants</h3><p>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).</p></div><div><h3>Main outcome measures</h3><p>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).</p></div><div><h3>Conclusions</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial\",\"authors\":\"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\",\"doi\":\"10.1016/j.ccrj.2023.06.007\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial.</p></div><div><h3>Design, setting, and participants</h3><p>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).</p></div><div><h3>Main outcome measures</h3><p>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).</p></div><div><h3>Conclusions</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).</p></div>\",\"PeriodicalId\":49215,\"journal\":{\"name\":\"Critical Care and Resuscitation\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2023-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Critical Care and Resuscitation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1441277223000285\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Critical Care and Resuscitation","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1441277223000285","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial
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).
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.
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