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Randomized Controlled Trial
. 2022 Jun;48(6):714-722.
doi: 10.1007/s00134-022-06695-0. Epub 2022 Apr 20.

Long-term mortality and health-related quality of life of lower versus higher oxygenation targets in ICU patients with severe hypoxaemia

Elena Crescioli  1   2   3 , Thomas Lass Klitgaard  1   2   3 , Lone Musaeus Poulsen  4 , Bjørn Anders Brand  5 , Martin Siegemund  6 , Thorbjørn Grøfte  7 , Frederik Keus  8 , Ulf Gøttrup Pedersen  9 , Minna Bäcklund  10 , Johanna Karttunen  11 , Matthew Morgan  12 , Andrei Ciubotariu  13 , Anne-Marie Gellert Bunzel  1 , Stine Rom Vestergaard  1 , Nicolaj Munch Jensen  1 , Thomas Steen Jensen  5 , Maj-Brit Nørregaard Kjær  3   5 , Aksel Karl Georg Jensen  14 , Theis Lange  14 , Jørn Wetterslev  15 , Anders Perner  3   5 , Olav Lilleholt Schjørring  1   2   3 , Bodil Steen Rasmussen  16   17   18
Affiliations
Randomized Controlled Trial

Long-term mortality and health-related quality of life of lower versus higher oxygenation targets in ICU patients with severe hypoxaemia

Elena Crescioli et al. Intensive Care Med. 2022 Jun.

Abstract

Purpose: We assessed outcomes after 1 year of lower versus higher oxygenation targets in intensive care unit (ICU) patients with severe hypoxaemia.

Methods: Pre-planned analyses evaluating 1-year mortality and health-related quality-of-life (HRQoL) outcomes in the previously published Handling Oxygenation Targets in the ICU trial which randomised 2928 adults with acute hypoxaemia to targets of arterial oxygen of 8 kPa or 12 kPa throughout the ICU stay up to 90 days. One-year all-cause mortality was assessed in the intention-to-treat population. HRQoL was assessed using EuroQol 5 dimensions 5 levels (EQ-5D-5L) questionnaire and EQ visual analogue scale score (EQ-VAS), and analyses were conducted in both survivors only and the intention-to-treat population with assignment of the worst scores to deceased patients.

Results: We obtained 1-year vital status for 2887/2928 (98.6%), and HRQoL for 2600/2928 (88.8%) of the trial population. One year after randomisation, 707/1442 patients (49%) in the lower oxygenation group vs. 704/1445 (48.7%) in the higher oxygenation group had died (adjusted risk ratio 1.00; 95% confidence interval 0.93-1.08, p = 0.92). In total, 1189/1476 (80.4%) 1-year survivors participated in HRQoL interviews: median EQ-VAS scores were 65 (interquartile range 50-80) in the lower oxygenation group versus 67 (50-80) in the higher oxygenation group (p = 0.98). None of the five EQ-5D-5L dimensions differed between groups.

Conclusion: Among adult ICU patients with severe hypoxaemia, a lower oxygenation target (8 kPa) did not improve survival or HRQoL at 1 year as compared to a higher oxygenation target (12 kPa).

Trial registration: ClinicalTrials.gov NCT03174002.

Keywords: Intensive care units; Mortality; Oxygen inhalation therapy; Quality of life; Randomized controlled trial.

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Conflict of interest statement

The Dept. of Anaesthesia and Intensive Care, Aalborg University Hospital (EC, BSR, OLS, TLK, AMGB, SRV) receives support for research from the Novo Nordisk Foundation, the Danish Ministry of Higher Education and Science, and AK Pharma. The Dept. of Intensive Care, Rigshospitalet (BB, MNK, AP) receives support for research from the Novo Nordisk Foundation, Sygeforsikringen ‘Danmark’, Pfizer, Fresenius Kabi, and AK Pharma. The Dept. of Anaesthesiology, Zealand University Hospital (LMP, UGP) receives support for research from AK Pharma.

Figures

Fig. 1
Fig. 1
Patient flow in the HOT-ICU trial. a1 patient in the lower oxygenation group with missing data at 90-day follow-up was included in the -year follow-up. *45/598 (7.5%) were completed by-proxy in the lower oxygenation group and 39/591 (6.6%) in the higher oxygenation group
Fig. 2
Fig. 2
Kaplan–Meier estimates of survival. Shown are the results of Kaplan–Meier analysis of data regarding survival, which was administratively censored at 365 days (adjusted hazard ratio 1.03; 95% confidence interval 0.92–1.14). The Cox proportional-hazards model was adjusted for the trial site, and for the presence or absence of chronic obstructive pulmonary disease and of active haematological malignancy
Fig. 3
Fig. 3
Distribution of EQ-5D-5L among survivors at 1 year from randomisation. EQ-5D-5L denotes EuroQol five dimensions five-level questionnaire [23, 24]. Values are from the responding survivors (n = 598 in the lower oxygenation group; n = 591 in the higher oxygenation group). The corresponding numeric data are presented in Table 2
See this image and copyright information in PMC

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