TY - JOUR
T1 - Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial
AU - LOGICAL management committee
AU - The Australian and New Zealand Intensive Care Society Clinical Trials Group
AU - Irish Critical Care-Clinical Trial
AU - Young, Paul J.
AU - Hodgson, Carol L.
AU - Mackle, Diane
AU - Mather, Anne M.
AU - Beasley, Richard
AU - Bellomo, Rinaldo
AU - Bernard, Stephen
AU - Brickell, Kathy
AU - Deane, Adam M.
AU - Eastwood, Glenn
AU - Finfer, Simon
AU - Higgins, Alisa M.
AU - Hunt, Anna
AU - Lawrence, Cassie
AU - Linke, Natalie J.
AU - Litton, Edward
AU - McDonald, Christine F.
AU - Moore, James
AU - Nichol, Alistair D.
AU - Olatunji, Shaanti
AU - Parke, Rachael L.
AU - Peake, Sandra
AU - Secombe, Paul
AU - Seppelt, Ian M.
AU - Turner, Anne
AU - Trapani, Tony
AU - Udy, Andrew
AU - Kasza, Jessica
PY - 2023/9
Y1 - 2023/9
N2 - 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).
AB - 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).
KW - Cardiac arrest
KW - Hyperoxia
KW - Hypoxia
KW - Hypoxic ischaemic encephalopathy
KW - Oxygen therapy
UR - http://www.scopus.com/inward/record.url?scp=85166131973&partnerID=8YFLogxK
U2 - 10.1016/j.ccrj.2023.06.007
DO - 10.1016/j.ccrj.2023.06.007
M3 - Article
C2 - 37876368
AN - SCOPUS:85166131973
SN - 1441-2772
VL - 25
SP - 140
EP - 146
JO - Critical Care and Resuscitation
JF - Critical Care and Resuscitation
IS - 3
ER -