Abstract
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.
Keywords: COVID-19; hypoxia; intensive care units; oxygen.
【저자키워드】 COVID-19, hypoxia, intensive care units, oxygen., 【초록키워드】 coronavirus disease, therapy, protocol, Respiratory failure, Mortality, Trial, intensive care, mechanical ventilation, hypoxia, hospital, intensive care unit, lung, oxygen, outcome, ICU, Randomized, intensive care units, Pulmonary function, Health, management, Lungs, Patient, ICU admission, target, ICU Patients, multicentre, Statistical analysis plan, Follow-up, Patient management, disease, Admission, patients, renal replacement therapy, Pragmatic, statistical analysis, COVID-19 patient, Oxygenation, life, replacement therapy, partial pressure, supplemental oxygen, cognitive, Serious Adverse Events, Serious Adverse Event, arterial partial pressure of oxygen, Supportive treatment, Primary outcome, Secondary outcomes, dosage, parallel-group, interim analysis, lower airways, absolute increase, hypoxaemic respiratory failure, Affect, secondary, ICU patient, Vasoactive, defined, detect, include, analyses, days alive, investigator-initiated, kPa, lower airway, with COVID-19, 【제목키워드】 Trial, target, Statistical analysis plan, Oxygenation, ICU patient,