Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial.
Cardiac arrest
Hyperoxia
Hypoxia
Hypoxic ischaemic encephalopathy
Oxygen therapy
Journal
Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine
ISSN: 1441-2772
Titre abrégé: Crit Care Resusc
Pays: Netherlands
ID NLM: 100888170
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
medline:
25
10
2023
pubmed:
25
10
2023
entrez:
25
10
2023
Statut:
epublish
Résumé
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. The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial. 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). 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). 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. Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial.
Design setting and participants
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).
Identifiants
pubmed: 37876368
doi: 10.1016/j.ccrj.2023.06.007
pii: S1441-2772(23)00028-5
pmc: PMC10581260
doi:
Types de publication
Journal Article
Langues
eng
Pagination
140-146Informations de copyright
© 2023 The Author(s).
Déclaration de conflit d'intérêts
Rinaldo Bellomo, Paul Young, Carol Hodgson, Andrew Udy, Adam Deane and Ed Litton declare a conflict of interest as Editors or Editorial Committee members of this journal.
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