Handling Oxygenation Targets in COVID-19

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory failure at ICU admission.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aalborg University Hospital
• Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research; Rigshospitalet, Denmark

Criteria

Inclusion Criteria:

• Acutely admitted to the ICU AND

• Aged ≥ 18 years AND

• Receives supplemental oxygen with a flow of at least 10 L per minutes in an open system including high-flow systems OR recieves supplemental oxygen in a closed system including invasive or non-invasive ventilation or continuous positive airway pressure (CPAP)-systems AND

• Expected to receive supplemental oxygen for at least 24 hours in the ICU AND

• Having an arterial line for PaO2 monitoring AND

• Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) in the time leading to or during current hospital admission

Exclusion Criteria:

• Cannot be randomised within twelve hours after present ICU admission

• Chronic mechanical ventilation for any reason

• Use of home oxygen

• Previous treatment with bleomycin

• Organ transplant during current hospital admission

• Withdrawal from active therapy or brain death deemed imminent

• Fertile woman (< 50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG

• Carbon monoxide poisoning

• Cyanide poisoning

• Methaemoglobinaemia

• Paraquat poisoning

• Any condition expected to involve the use of hyperbaric oxygen (HBO)

• Sickle cell disease

• Consent not obtainable according to national regulations

• Previously randomised into the HOT-COVID trial