Hypoxemic Respiratory Failure, Oxygen Toxicity
Conditions
Keywords
Oxygenation, Acute Respiratory Distress Syndrome, Mechanical ventilation, Critical illness, Critical care
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.
Interventions
DRUGOxygen
Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
Sponsors
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-days mortality | 90 days | Landmark mortality 90-days after randomisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days alive out of the hospital | Within 90 days | Percentage of days alive out of the hospital |
| Number of patients with one or more serious adverse events | Until ICU discharge, maximum 90 days | Serious adverse events are defined as new episode of shock and new episodes of ischaemic events including myocardial or intestinal ischaemia or ischaemic stroke |
| 1-year mortality | 1 year | Landmark mortality 1 year after randomisation |
| Days alive without organ support | Within 90 days | Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy |
| 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 | RBANS score 1 year after randomisation at selected sites |
| Pulmonary function | 1 year | Bodyplethysmography and carbon monooxide diffusion capacity 1 year after randomisation at sellected sites |
| A health economic analysis | 90 days | The analytic details will be based on the result of the trial and specified (cost-effectiveness versus cost-minimisation analyses) |
| Quality of life assessement using the EuroQual-5D-5L telephone interview in selcted sites | 1 year | EQ-5D-5L 1-year after randomisation |
Countries
Denmark, Finland, Iceland, Netherlands, Norway, Switzerland, United Kingdom
Outcome results
None listed