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
Overview
- Phase
- Phase 4
- Intervention
- Oxygen
- Conditions
- Hypoxemic Respiratory Failure
- Sponsor
- Aalborg University Hospital
- Enrollment
- 2928
- Locations
- 37
- Primary Endpoint
- 90-days mortality
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
Acutely ill adults with hypoxaemic respiratory failure admitted to the intensive care unit (ICU) are at risk of life-threatening hypoxia, and thus oxygen is administered. However, the evidence on the optimal level of oxygenation is of low quantity and quality with no firm evidence for benefit or harm. Importantly, liberal use of supplementary oxygen may increase the number of serious adverse events including death. The aim of the HOT-ICU trial is to assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.
Investigators
Bodil Steen Rasmussen
Clinical Professor, MD, PhD
Aalborg University Hospital
Eligibility 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
Arms & Interventions
Low oxygenation target
Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)
Intervention: Oxygen
High oxygenation target
Partial pressure of oxygen in arterial blood (PaO2) 12 kPa (90 mmHg)
Intervention: Oxygen
Outcomes
Primary Outcomes
90-days mortality
Time Frame: 90 days
Landmark mortality 90-days after randomisation
Secondary Outcomes
- Pulmonary function(1 year)
- A health economic analysis(90 days)
- 1-year mortality(1 year)
- Quality of life assessement using the EuroQual-5D-5L telephone interview in selcted sites(1 year)
- Cognitive function 1-year after randomisation as assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score in selected sites(1 year)
- Days alive without organ support(Within 90 days)
- Number of patients with one or more serious adverse events(Until ICU discharge, maximum 90 days)
- Days alive out of the hospital(Within 90 days)