HOT-ICU Handling Oxygenation Targets in the Intensive Care Unit
Research type
Research Study
Full title
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
IRAS ID
254478
Contact name
Matt Wise
Contact email
Sponsor organisation
Aalborg University Hospital
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
017-000632-34, EudraCT number
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Research Summary
Very sick adults admitted to the Intensive Care Unit with lung failure are all treated with oxygen. Many will need a life support machine (ventilator) to help support their breathing. Although there have been many trials that aim to reduce the harms from using ventilators, these provide no recommendations regarding oxygen levels. The optimal 'dose' or level of oxygen to administer through this machine is unknown. What evidence does exist is of low quantity and quality.
There is a global trend to use oxygen very liberally. However, there is gathering evidence that high levels of oxygen use has potentially harmful effects. There have been small scale trials comparing higher and lower oxygen targets which shown no significant differences in survival between groups. There is therefore a need for larger scale, randomised controlled trial to decide this important issue.
The aim of the HOT-ICU international, multi-centre study aiming to recruit 2,928 patients. It aims to test which of two different accepted oxygen targets are best to use when treating very sick adult patients with lung failure early in their illness.
All adult patients admitted to an intensive care, who already have an oxygen monitoring line inserted and need high levels of supplementary oxygen, are eligible for inclusion in the trial. Those randomised will be targeted to normal (8kPa) or higher levels (12kPa) of oxygen for the duration of their ICU stay. Patients will be followed up for one year after randomisation with quality of life questionnaires and cognitive assessments.
Summary of Results
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.
Patients admitted to Intensive Care with respiratory failure are treated with oxygen via a ventilator or oxygen mask, however the appropriate oxygenation level/target is not universally agreed upon.
HOT ICU was designed to assess the benefits and harms of different oxygenation levels in patients admitted to Intensive Care with respiratory failure. The main question of the research was 'does a lower oxygenation target lower mortality at 90 days compared with a higher oxygenation target, in patients admitted to Intensive Care with respiratory failure'.
As the HOT ICU trial was coming to a close the COVID 19 pandemic started so the trial team made the decision to ask the same research question for COVID 19 patients in Intensive Care as, at the time, there was no evidence for an appropriate oxygenation target for these patients. Therefore, the trial morphed in to HOT COVID.
The trial was led by a team of researchers in Denmark who are part of the Collaboration for Research in Intensive group (CRIC) To read more about them and their work follow this link - About CRIC - CRIC - Collaboration for Research in Intensive Care) The study was funded by Innovation Fund Denmark and recruited in Denmark, Finland, Norway, Iceland, Switzerland, The Netherlands and the UK.
In the UK the study was led by Dr Matt Morgan from Cardiff and Vale University Health Board and Cardiff with 6 sites recruiting across the UK.
2928 patients were recruited to the HOT ICU trial with 50% assigned to a lower oxygenation target and 50% assigned to a higher oxygenation target. Patients were recruited within 12 hours of being admitted to Intensive Care and the oxygenation target continued until discharge from Intensive Care. During this time patients regularly had their oxygen levels measured, as is usual practice within Intensive Care, and were assessed for any safety concerns. Patients were followed up at 90 days and 1 year to assess survival and quality of life.
726 patients were recruited to the HOT COVID trial and they followed the same pathway.
The HOT ICU trial showed there was no difference between the two groups meaning a lower oxygen target did not result lower incidence of death at 90 days.
The HOT COVID trial showed that the group assigned to a lower oxygenation target had more days alive without life support than the group assigned to higher oxygenation target.
There was no difference in the number of adverse events in either group for both trials.
Read the full paper here:
HOT ICU: Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure | New England Journal of Medicine HOT COVID: Lower vs Higher Oxygenation Target and Days Alive Without Life Support in COVID-19: The HOT-COVID Randomized Clinical Trial | Coronavirus (COVID-19) | JAMA | JAMA NetworkREC name
Wales REC 3
REC reference
19/WA/0082
Date of REC Opinion
14 May 2019
REC opinion
Further Information Favourable Opinion