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Acta Anaesthesiol Scand. 2019 Mar 18. doi: 10.1111/aas.13356. [Epub ahead of print]

Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)-Protocol for a randomised clinical trial comparing a lower vs a higher oxygenation target in adults with acute hypoxaemic respiratory failure.

Author information

1
Department of Anaesthesia and Intensive Care Medicine, Aalborg University Hospital, Aalborg, Denmark.
2
Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
3
Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
4
Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
5
Copenhagen Trial Unit, Department 7812, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
6
Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
7
Center for Statistical Science, Peking University, Peking, China.
8
Department of Critical Care, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
9
Division of Emergencies and Critical Care, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
10
Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki, Finland.
11
Department of Anaesthesia and Intensive Care, University Hospital Basel, Basel, Switzerland.
12
Critical Care Research, University Hospital of Wales, Cardiff, UK.
13
Cardiff University School of Medicine, Wales, UK.
14
Department of Anaesthesia and Intensive Care, University Hospital Reykjavik, Landspitali, Reykjavik, Iceland.

Abstract

BACKGROUND:

Acutely ill adults with hypoxaemic respiratory failure are at risk of life-threatening hypoxia, and thus oxygen is often administered liberally. Excessive oxygen use may, however, increase the number of serious adverse events, including death. Establishing the optimal oxygenation level is important as existing evidence is of low quality. We hypothesise that targeting an arterial partial pressure of oxygen (PaO2 ) of 8 kPa is superior to targeting a PaO2 of 12 kPa in adult intensive care unit (ICU) patients with acute hypoxaemic respiratory failure.

METHODS:

The Handling Oxygenation Targets in the ICU (HOT-ICU) trial is an outcome assessment blinded, multicentre, randomised, parallel-group trial targeting PaO2 in acutely ill adults with hypoxaemic respiratory failure within 12 hours after ICU admission. Patients are randomised 1:1 to one of the two PaO2 targets throughout ICU stay until a maximum of 90 days. The primary outcome is 90-day mortality. Secondary outcomes are serious adverse events in the ICU, days alive without organ support and days alive out of hospital in the 90-day period; mortality, health-related quality-of-life at 1-year follow-up as well as 1-year cognitive and pulmonary function in a subgroup; and an overall health economic analysis. To detect or reject a 20% relative risk reduction, we aim to include 2928 patients. An interim analysis is planned after 90-day follow-up of 1464 patients.

CONCLUSION:

The HOT-ICU trial will test the hypothesis that a lower oxygenation target reduces 90-day mortality compared with a higher oxygenation target in adult ICU patients with acute hypoxaemic respiratory failure.

KEYWORDS:

critical illness; hyperoxia; hypoxia; intensive care units; mortality; oxygen inhalation therapy; pragmatic clinical trial; randomised controlled trial; respiratory insufficiency

PMID:
30883686
DOI:
10.1111/aas.13356

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