Status:
COMPLETED
Handling Oxygenation Targets in COVID-19
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Conditions:
Hypoxemic Respiratory Failure
Oxygen Toxicity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 regar...
Detailed Description
Acutely ill adult COVID-19 patients with hypoxaemic respiratory failure admitted to the intensive care unit (ICU) are at risk of life-threatening hypoxia, and are provided supplementary oxygen. Libera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2024
Estimated Enrollment :
726 Patients enrolled
Trial Details
Trial ID
NCT04425031
Start Date
August 25 2020
End Date
March 8 2024
Last Update
July 15 2024
Active Locations (10)
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1
Dept. of Intensive Care, Aalborg University Hospital
Aalborg, Denmark, 9000
2
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
3
Dept. of Intensive Care, Herlev Hospital
Herlev, Denmark, 2730
4
Dept. of Intensive Care, Hillerød Hospital
Hillerød, Denmark, 3400