EUCTR2017-000632-34-FIActive, not recruitingPhase 1
Handling oxygenation targets in adults with acute hypoxaemic respiratory failure in the intensive care unit: A randomised clinical trial of a lower versus a higher oxygenation target - Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)
Department of Anaesthesia and Intensive Care Medicine, Aalborg University Hospital0 sites2,928 target enrollmentStarted: February 6, 2018Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,928
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Acutely admitted to the intensive care unit AND
- •- Aged = 18 years AND
- •- Receive supplemental oxygen with a flow of at least 10 L per minute in an open system or at least an fraction of inspired oxygen of 0.50 in a closed system, including invasive ventilation, non-invasive ventilation or continuous positive airway pressure AND
- •- Are expected to receive oxygen administration for at least 24 hours in the ICU AND
- •- Have an arterial line in place
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1312
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1616
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 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-ICU trial
Investigators
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