NCT03174002

Handling Oxygenation Targets in the Intensive Care Unit

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,928 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxemic Respiratory Failure
• Oxygen Toxicity

Interventions

Type	Name	Description
DRUG	Oxygen	Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
DRUG	Oxygen	Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge

Timeline

• Start date: 2017-06-19
• Primary completion: 2020-11-03
• Completion: 2021-08-03
• First posted: 2017-06-02
• Last updated: 2021-10-26

Locations

37 sites across 7 countries: Denmark, Finland, Iceland, Netherlands, Norway, Switzerland, United Kingdom