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Acta Anaesthesiol Scand
. 2024 Jan 25.
doi: 10.1111/aas.14379. Online ahead of print. Long-term cognitive and pulmonary functions following a lower versus a higher oxygenation target in the HOT-ICU and HOT-COVID trials: A protocol update
Elena Crescioli 1 2 , Jens Østergaard Riis 3 , Ulla Møller Weinreich 2 4 , Jens Ulrik Staehr Jensen 5 , Lone Musaeus Poulsen 6 , Anne Craveiro Brøchner 7 , Theis Lange 8 , Anders Perner 9 , Thomas Lass Klitgaard 1 , Olav Lilleholt Schjørring 1 2 , Bodil Steen Rasmussen 1 2
Affiliations
Background: The Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial was a multicentre, randomised, parallel-group trial of a lower oxygenation target (arterial partial pressure of oxygen [PaO2 ] = 8 kPa) versus a higher oxygenation target (PaO2 = 12 kPa) in adult ICU patients with acute hypoxaemic respiratory failure; the Handling Oxygenation Targets in coronavirus disease 2019 (HOT-COVID) tested the same oxygenation targets in patients with confirmed COVID-19. In this study, we aim to evaluate the long-term effects of these oxygenation targets on cognitive and pulmonary function. We hypothesise that a lower oxygenation target throughout the ICU stay may result in cognitive impairment, whereas a higher oxygenation target may result in impaired pulmonary function.
Methods: This is the updated protocol and statistical analysis plan of two pre-planned secondary outcomes, the long-term cognitive function, and long-term pulmonary function, in the HOT-ICU and HOT-COVID trials. Patients enrolled in both trials at selected Danish sites and surviving to 1 year after randomisation are eligible to participate. A Repeatable Battery for the Assessment of Neuropsychological Status score and a full-body plethysmography, including diffusion capacity for carbon monoxide, will be obtained. The last patient is expected to be included in the spring of 2024.
Conclusion: This study will provide important information on the long-term effects of a lower versus a higher oxygenation target on long-term cognitive and pulmonary functions in adult ICU patients with acute hypoxaemic respiratory failure.
Keywords: ICU; clinical trial; critical care outcomes; oxygen inhalation therapy.
. 2024 Jan 25.
doi: 10.1111/aas.14379. Online ahead of print. Long-term cognitive and pulmonary functions following a lower versus a higher oxygenation target in the HOT-ICU and HOT-COVID trials: A protocol update
Elena Crescioli 1 2 , Jens Østergaard Riis 3 , Ulla Møller Weinreich 2 4 , Jens Ulrik Staehr Jensen 5 , Lone Musaeus Poulsen 6 , Anne Craveiro Brøchner 7 , Theis Lange 8 , Anders Perner 9 , Thomas Lass Klitgaard 1 , Olav Lilleholt Schjørring 1 2 , Bodil Steen Rasmussen 1 2
Affiliations
- PMID: 38272985
- DOI: 10.1111/aas.14379
Background: The Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial was a multicentre, randomised, parallel-group trial of a lower oxygenation target (arterial partial pressure of oxygen [PaO2 ] = 8 kPa) versus a higher oxygenation target (PaO2 = 12 kPa) in adult ICU patients with acute hypoxaemic respiratory failure; the Handling Oxygenation Targets in coronavirus disease 2019 (HOT-COVID) tested the same oxygenation targets in patients with confirmed COVID-19. In this study, we aim to evaluate the long-term effects of these oxygenation targets on cognitive and pulmonary function. We hypothesise that a lower oxygenation target throughout the ICU stay may result in cognitive impairment, whereas a higher oxygenation target may result in impaired pulmonary function.
Methods: This is the updated protocol and statistical analysis plan of two pre-planned secondary outcomes, the long-term cognitive function, and long-term pulmonary function, in the HOT-ICU and HOT-COVID trials. Patients enrolled in both trials at selected Danish sites and surviving to 1 year after randomisation are eligible to participate. A Repeatable Battery for the Assessment of Neuropsychological Status score and a full-body plethysmography, including diffusion capacity for carbon monoxide, will be obtained. The last patient is expected to be included in the spring of 2024.
Conclusion: This study will provide important information on the long-term effects of a lower versus a higher oxygenation target on long-term cognitive and pulmonary functions in adult ICU patients with acute hypoxaemic respiratory failure.
Keywords: ICU; clinical trial; critical care outcomes; oxygen inhalation therapy.