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Randomized Controlled Trial
. 2024 Oct;50(10):1603-1613.
doi: 10.1007/s00134-024-07613-2. Epub 2024 Sep 5.

Long-term mortality and health-related quality of life with lower versus higher oxygenation targets in intensive care unit patients with COVID-19 and severe hypoxaemia

Elena Crescioli  1   2 , Frederik Mølgaard Nielsen  3   4 , Anne-Marie Bunzel  3 , Anne Sofie Broberg Eriksen  3 , Martin Siegemund  5 , Lone Musaeus Poulsen  6 , Anne Sofie Andreasen  7 , Morten Heiberg Bestle  8   9 , Susanne Andi Iversen  10 , Anne Craveiro Brøchner  11 , Thorbjørn Grøfte  12 , Thomas Hildebrandt  13 , Jon Henrik Laake  14 , Maj-Brit Nørregaard Kjær  15 , Theis Lange  16 , Anders Perner  9   15 , Thomas Lass Klitgaard  3 , Olav Lilleholt Schjørring  3   4 , Bodil Steen Rasmussen  3   4
Affiliations
Randomized Controlled Trial

Long-term mortality and health-related quality of life with lower versus higher oxygenation targets in intensive care unit patients with COVID-19 and severe hypoxaemia

Elena Crescioli et al. Intensive Care Med. 2024 Oct.

Abstract

Purpose: The aim of this study was to evaluate one-year outcomes of lower versus higher oxygenation targets in intensive care unit (ICU) patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia.

Methods: We conducted pre-planned analyses of one-year mortality and health-related quality of life (HRQoL) in the Handling Oxygenation Targets in COVID-19 trial. The trial randomised 726 ICU patients with COVID-19 and hypoxaemia to partial pressure of arterial oxygen targets of 8 kPa (60 mmHg) versus 12 kPa (90 mmHg) during ICU stay up to 90 days, including readmissions. HRQoL was assessed using EuroQol visual analogue scale (EQ-VAS) and 5-level 5-dimension questionnaire (EQ-5D-5L). Outcomes were analysed in the intention-to-treat population. Non-survivors were assigned the worst possible score (zero), and multiple imputation was applied for missing EQ-VAS values.

Results: We obtained one-year vital status for 691/726 (95.2%) of patients and HRQoL data for 642/726 (88.4%). At one year, 117/348 (33.6%) of patients in the lower-oxygenation group had died compared to 134/343 (39.1%) in the higher-oxygenation group (adjusted risk ratio: 0.85; 98.6% confidence interval (CI) 0.66-1.09; p = 0.11). Median EQ-VAS was 50 (interquartile range, 0-80) versus 40 (0-75) (adjusted mean difference: 4.8; 98.6% CI - 2.2 to 11.9; p = 0.09) and EQ-5D-5L index values were 0.61 (0-0.81) in the lower-oxygenation group versus 0.43 (0-0.79) (p = 0.20) in the higher-oxygenation group, respectively.

Conclusion: Among adult ICU patients with COVID-19 and severe hypoxaemia, one-year mortality results were most compatible with benefit of the lower oxygenation target, which did not appear to result in more survivors with poor quality of life.

Keywords: COVID-19; Intensive care units; Mortality; Oxygen inhalation therapy; Quality of life.

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Conflict of interest statement

The Department of Intensive Care at Rigshospitalet (AP, MNK) received funding from Sygeforsikringen “Danmark”, The Novo Nordisk Foundation, the Ehrenreich Foundation, the Becketts Foundation, and AM-Pharma. TL has served in Data and Safety Monitoring Board for Novo Nordisk and Leo Pharma, respectively: the studies were unrelated to the present study.

Figures

Fig. 1
Fig. 1
Patient flow in the Handling Oxygenation Targets in COVID trial
Fig. 2
Fig. 2
Kaplan–Meier plots of survival and distribution of Euro-QoL Visual Analogue Scale data. a) Shown are the Kaplan–Meier plots of survival, which were administratively censored at 365 days. Hazard ratio (HR) from trial site adjusted Cox proportional hazards model. b) Distribution of EuroQol Visual Analogue Scale (EQ-VAS) data as horizontally stacked proportions in the two groups; non-survivors were assigned a score of zero. Scores range from 0 to 100 and are represented by a colour scale ranging from red (worse outcomes) to blue (better outcomes) as illustrated in the legend. The horizontal axis represents the cumulated proportions of patients scoring at or below the corresponding value depicted in the legend
Fig. 3
Fig. 3
Distribution of EQ-5D-5L among survivors after one year, ranging from no to extreme problems in each of the five dimensions. EQ-5D-5L denotes EuroQol 5-dimension 5-level questionnaire. Values range from no to extreme problems. Data from responding survivors: 208 in the lower-oxygenation group and 183 in the higher-oxygenation group. The corresponding numeric data are presented in Table S6 in the ESM 1
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