tetano
Editor, Senior Moderator
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[SUP] 1 2 [/SUP], Jens Østergaard Riis[SUP] 3 [/SUP], Ulla Møller Weinreich[SUP] 2 4 [/SUP], Jens Ulrik Staehr Jensen[SUP] 5 [/SUP], Lone Musaeus Poulsen[SUP] 6 [/SUP], Anne Craveiro Brøchner[SUP] 7 [/SUP], Theis Lange[SUP] 8 [/SUP], Anders Perner[SUP] 9 [/SUP], Thomas Lass Klitgaard[SUP] 1 [/SUP], Olav Lilleholt Schjørring[SUP] 1 2 [/SUP], Bodil Steen Rasmussen[SUP] 1 2 [/SUP]
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 [PaO[SUB]2[/SUB] ] = 8 kPa) versus a higher oxygenation target (PaO[SUB]2[/SUB] = 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[SUP] 1 2 [/SUP], Jens Østergaard Riis[SUP] 3 [/SUP], Ulla Møller Weinreich[SUP] 2 4 [/SUP], Jens Ulrik Staehr Jensen[SUP] 5 [/SUP], Lone Musaeus Poulsen[SUP] 6 [/SUP], Anne Craveiro Brøchner[SUP] 7 [/SUP], Theis Lange[SUP] 8 [/SUP], Anders Perner[SUP] 9 [/SUP], Thomas Lass Klitgaard[SUP] 1 [/SUP], Olav Lilleholt Schjørring[SUP] 1 2 [/SUP], Bodil Steen Rasmussen[SUP] 1 2 [/SUP]
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 [PaO[SUB]2[/SUB] ] = 8 kPa) versus a higher oxygenation target (PaO[SUB]2[/SUB] = 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.