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

Crescioli, Elena; Klitgaard, Thomas; Poulsen, Lone Musaeus; Brand, Björn; Siegemund, Martin; Grøfte, Thorbjørn; Keus, Frederik; Pedersen, Ulf Gøttrup; Bäcklund, Minna; Karttunen, Johanna; Kift-Morgan, Ann; Ciubotariu, Andrei; Bunzel, Anne-Marie Gellert; Vestergaard, Stine Rom; Jensen, Nicolaj Munch; Jensen, Thomas Steen; Kjær, Maj‐Brit Nørregaard; Jensen, Aksel Karl Georg; Lange, Theis; Wetterslev, Jørn; Perner, Anders; Schjørring, Olav Lilleholt; Rasmussen, Bodil Steen

doi:10.1007/s00134-022-06695-0

Cited by 14 publications

(16 citation statements)

References 35 publications

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“…This study was conducted according to a protocol and statistical analysis plan published prior to the conduct of the analysis and before HRQoL-follow-up was completed for one of the included trials. 11,17,18 This manuscript was prepared in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist 19 (Data S1).…”

Section: Methodsmentioning

confidence: 99%

“…The sample size was fixed to the relevant intention-to-treat populations from the COVID STEROID 2 and HOT-ICU trials, that is, 982 patients (615 survivors at HRQoL-follow-up) and 2910 patients (1476 survivors at HRQoL-follow-up), respectively. 12,17,18,20 Consequently, formal sample size calculation was forgone. 11…”

Section: Sample Sizementioning

confidence: 99%

“…HRQoL was assessed by either phone or mail 12,17,18,[20][21][22] using the EQ-5D-5L survey 23 consisting of EQ VAS and five HRQoL domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression; five levels each) used to calculate EQ-5D-5L index values.…”

Section: All-cause Mortalitymentioning

confidence: 99%

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Association between days alive without life support/out of hospital and health‐related quality of life

Granholm

Schjørring

Jensen

et al. 2023

Acta Anaesthesiol Scand

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Background Trials in critically ill patients increasingly focus on days alive without life support (DAWOLS) or days alive out of hospital (DAOOH) and health‐related quality of life (HRQoL). DAWOLS and DAOOH convey more information than mortality and are simpler and faster to collect than HRQoL. However, whether these outcomes are associated with HRQoL is uncertain. We thus aimed to assess the associations between DAWOLS and DAOOH and long‐term HRQoL. Methods Secondary analysis of the COVID STEROID 2 trial including adults with COVID‐19 and severe hypoxaemia and the Handling Oxygenation Targets in the Intensive Care Unit (HOT‐ICU) trial including adult intensive care unit patients with acute hypoxaemic respiratory failure. Associations between DAWOLS and DAOOH at day 28 and 90 and long‐term HRQoL (after 6 or 12 months) using the EuroQol 5‐dimension 5‐level survey (EQ VAS and EQ‐5D‐5L index values) were assessed using flexible models and evaluated using measures of fit and prediction adequacy in both datasets (comprising internal performance and external validation), non‐parametric correlation coefficients and graphical presentations. Results We found no strong associations between DAWOLS or DAOOH and HRQoL in survivors at HRQoL‐follow‐up (615 and 1476 patients, respectively). There was substantial variability in outcomes, and predictions from the best fitted models were poor both internally and externally in the other trial dataset, which also showed inadequate calibration. Moderate associations were found when including non‐survivors, although predictions remained uncertain and calibration inadequate. Conclusion DAWOLS and DAOOH were poorly associated with HRQoL in adult survivors of severe or critical illness included in the COVID STEROID 2 and HOT‐ICU trials.

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Section: Methodsmentioning

confidence: 99%

Section: Sample Sizementioning

confidence: 99%

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Association between days alive without life support/out of hospital and health‐related quality of life

Granholm

Schjørring

Jensen

et al. 2023

Acta Anaesthesiol Scand

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“…In a general population of ICU patients and in patients with acute respiratory disease syndrome (ARDS), an unadjusted analysis shows a U-shaped relationship between the arterial partial pressure of oxygen and mortality, with higher mortality in both hypoxemic and hyperoxemic patients [5,6]. Conservative oxygenation targets aimed at avoiding hyperoxemia are not associated with short- or long-term mortality, nor are they associated with ventilator-free days benefits in ICU patients with acute respiratory failure [7 ▪▪ ,8 ▪▪ ,9,10 ▪▪ ]. However, in one of those trials, episodes of hypoxemia < 55 mmHg were more frequent in the conservative oxygenation target group and the study was stopped prematurely because this group presented with higher mortality [7 ▪▪ ].…”

Section: Closed-loop Control Of Oxygenationmentioning

confidence: 99%

Closed-loop ventilation

Arnal

Katayama

Howard

2022

Current Opinion in Critical Care

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Purpose of reviewThe last 25 years have seen considerable development in modes of closed-loop ventilation and there are now several of them commercially available. They not only offer potential benefits for the individual patient, but may also improve the organization within the intensive care unit (ICU). Clinicians are showing both greater interest and willingness to address the issues of a caregiver shortage and overload of bedside work in the ICU. This article reviews the clinical benefits of using closed-loop ventilation modes, with a focus on control of oxygenation, lung protection, and weaning.Recent findingsClosed-loop ventilation modes are able to maintain important physiological variables, such as oxygen saturation measured by pulse oximetry, tidal volume (VT), driving pressure (ΔP), and mechanical power (MP), within target ranges aimed at ensuring continuous lung protection. In addition, these modes adapt the ventilator support to the patient's needs, promoting diaphragm activity and preventing over-assistance. Some studies have shown the potential of these modes to reduce the duration of both weaning and mechanical ventilation.SummaryRecent studies have primarily demonstrated the safety, efficacy, and feasibility of using closed-loop ventilation modes in the ICU and postsurgery patients. Large, multicenter randomized controlled trials are needed to assess their impact on important short- and long-term clinical outcomes, the organization of the ICU, and cost-effectiveness.

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“…The smallest trial was, however, stopped prematurely for mesenteric ischaemia in 5 of the 99 patients in the lower oxygen target group 24. The effects of oxygen targets on long-term outcomes have been evaluated in two recent trials, one of which found potentially better functional outcomes with lower SpO 2 targets, particularly among patients who had experienced cardiac arrest prior to enrolment, and one which did not find differences in long-term mortality or health-related quality of life between higher and lower targets 23 25…”

Section: Introductionmentioning

confidence: 99%

Cognitive Outcomes in the Pragmatic Investigation of optimaL Oxygen Targets (CO-PILOT) trial: protocol and statistical analysis plan

et al. 2022

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IntroductionLong-term cognitive impairment is one of the most common complications of critical illness among survivors who receive mechanical ventilation. Recommended oxygen targets during mechanical ventilation vary among international guidelines. Different oxygen targets during mechanical ventilation have the potential to alter long-term cognitive function due to cerebral hypoxemia or hyperoxemia. Whether higher, intermediate or lower SpO2targets are associated with better cognitive function at 12-month follow-up is unknown.Methods and analysisThePragmaticInvestigation of optimaL OxygenTargets (PILOT) trial is an ongoing pragmatic, cluster-randomised, cluster-crossover trial comparing the effect of a higher SpO2target (target 98%, goal range 96%–100%), an intermediate SpO2target (target 94%, goal range 92%–96%) and a lower SpO2target (target 90%, goal range 88%–92%) on clinical outcomes in mechanically ventilated patients admitted to the medical intensive care unit at a single centre in the USA. For this ancillary study of long-termCognitiveOutcomes (CO-PILOT), survivors of critical illness who are in the PILOT trial and who do not meet exclusion criteria for CO-PILOT are approached for consent. The anticipated number of patients for whom assessment of long-term cognition will be performed in CO-PILOT is 612 patients over 36 months of enrolment. Cognitive, functional and quality of life assessments are assessed via telephone interview at approximately 12 months after enrolment in PILOT. The primary outcome of CO-PILOT is the telephone version of the Montreal Cognitive Assessment. A subset of patients will also complete a comprehensive neuropsychological telephone battery to better characterise the cognitive domains affected.Ethics and disseminationThe CO-PILOT ancillary study was approved by the Vanderbilt Institutional Review Board. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

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

Cited by 14 publications

References 35 publications

Association between days alive without life support/out of hospital and health‐related quality of life

Association between days alive without life support/out of hospital and health‐related quality of life

Closed-loop ventilation

Cognitive Outcomes in the Pragmatic Investigation of optimaL Oxygen Targets (CO-PILOT) trial: protocol and statistical analysis plan

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