Handling Oxygenation Targets in the Intensive Care Unit

• Status: Completed
• Trial end date: 2021-08-03
• Target enrollment: 0
• Participant gender: All

Summary

Handling oxygenation targets (HOT) is standard of care in the intensive care unit (ICU), however the quality and quantity of evidence is low and potential harm has been reported. The aim of the HOT-ICU trial is to assess the overall benefits and harms of two levels of oxygenation targets in adult critically ill patients with acute hypoxaemic respiratory failure in the ICU.

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

Details

• Lead Sponsor: Aalborg Universitetshospital; 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 at least a FiO2 of 0.50 in a closed system including invasive or non-invasive ventilation or CPAP systems AND

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

• Having an arterial line for PaO2 monitoring

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-ICU trial