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Handling oxygenation targets in ICU patients with COVID‐19—Protocol and statistical analysis plan in the HOT‐COVID trial
Author(s) -
Mølgaard Nielsen Frederik,
Lass Klitgaard Thomas,
Crescioli Elena,
Rosborg Aagaard Søren,
Andreasen Anne Sofie,
Musaeus Poulsen Lone,
Siegemund Martin,
Craveiro Brøchner Anne,
Bestle Morten H.,
Andi Iversen Susanne,
Brand Björn A.,
Laake Jon Henrik,
Grøfte Thorbjørn,
Hildebrandt Thomas,
Lange Theis,
Perner Anders,
Lilleholt Schjørring Olav,
Steen Rasmussen Bodil
Publication year - 2021
Publication title -
acta anaesthesiologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.738
H-Index - 107
eISSN - 1399-6576
pISSN - 0001-5172
DOI - 10.1111/aas.13956
Subject(s) - medicine , interim analysis , intensive care unit , extracorporeal membrane oxygenation , oxygenation , randomized controlled trial , mechanical ventilation , adverse effect , life support , renal replacement therapy , quality of life (healthcare) , intensive care , intensive care medicine , subgroup analysis , covid-19 , emergency medicine , anesthesia , disease , confidence interval , infectious disease (medical specialty) , nursing
Background Coronavirus disease (COVID‐19) primarily affects the lungs and lower airways and may present as hypoxaemic respiratory failure requiring admission to an intensive care unit (ICU) for supportive treatment. Here, supplemental oxygen remains essential for COVID‐19 patient management, but the optimal dosage is not defined. We hypothesize that targeting an arterial partial pressure of oxygen of 8 kPa throughout ICU admission is superior to targeting 12 kPa. Methods The Handling Oxygenation Targets in ICU patients with COVID‐19 (HOT‐COVID) trial, is an investigator‐initiated, pragmatic, multicentre, randomized, parallel‐group trial comparing a lower oxygenation target versus a higher oxygenation target in adult ICU patients with COVID‐19. The primary outcome is days alive without life‐support (use of mechanical ventilation, renal replacement therapy or vasoactive therapy) at day 90. Secondary outcomes are 90‐day and 1‐year mortality, serious adverse events in the ICU and days alive and out of hospital in the 90‐day period, health‐related quality‐of‐life at 1 year, and health economic analyses. One‐year follow‐up of cognitive and pulmonary function is planned in a subgroup of Danish patients. We will include 780 patients to detect or reject an absolute increase in days alive without life‐support of 7 days with an α of 5% and a β of 20%. An interim analysis is planned after 90‐day follow‐up of 390 patients. Conclusions The HOT‐COVID trial will provide patient‐important data on the effect of two oxygenation targets in ICU patients with COVID‐19 and hypoxia. This protocol paper describes the background, design and statistical analysis plan for the trial.