Higher versus lower fraction of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit

Barbateskovic, Marija; Schjørring, Olav Lilleholt; Krauss, Sara Russo; Jakobsen, Janus Christian; Meyhoff, Christian S.; Dahl, R; Rasmussen, Bodil Steen; Perner, Anders; Wetterslev, Jørn

doi:10.1002/14651858.cd012631.pub2

Cited by 63 publications

(83 citation statements)

References 140 publications

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“…This means that our prior beliefs will have minimal influence on the study results. Two sensitivity analyses will be conducted using evidence‐based (based on previous research) 2‐5 and sceptic priors for the parameters of interest; additional technical details on models and priors (including justifications) are presented in the supplement.…”

Section: Methodsmentioning

confidence: 99%

“…A recent Cochrane review of lower versus higher oxygenation levels in adult ICU patients reported a statistically significant increase in mortality with higher oxygenation (relative risk (RR) 1.18, 95% confidence interval (CI): 1.01 to 1.37). However, the certainty of evidence was very low due to risk of bias, differences in oxygenation levels in the included trials, and sparse data 2 . The recent multicentre Intensive Care Unit Randomised Trial Comparing Two Approaches to Oxygen Therapy (ICU‐ROX) trial (n = 1000 adult ICU patients) demonstrated no difference in both 28‐day ventilator‐free days and mortality when comparing the conservative and usual oxygen therapy groups 3 .…”

Section: Introductionmentioning

confidence: 99%

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Bayesian and heterogeneity of treatment effect analyses of the HOT‐ICU trial—A secondary analysis protocol

Klitgaard

Schjørring

Lange

et al. 2020

Acta Anaesthesiol Scand

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Background The Handling Oxygenation Targets in the Intensive Care Unit (HOT‐ICU) trial is an ongoing randomised clinical trial exploring the benefits and harms of targeting a lower (8 kPa) versus a higher (12 kPa) arterial oxygenation target in adult patients acutely admitted to the intensive care unit (ICU) with hypoxaemic respiratory failure. Methods This protocol describes a secondary analysis of the primary trial outcome, 90‐day all‐cause mortality. We will analyse the primary outcome using Bayesian methods, which allows quantification of probabilities of all effect sizes. We will explore the presence of heterogeneity of treatment effects (HTE) using Bayesian hierarchical models in subgroups based on baseline parameters: (a) severity of illness (Sequential Organ Failure Assessment (SOFA) score), (b) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio), (c) vasopressor requirement (highest noradrenaline dose in the 24 hours prior to randomisation), and (d) plasma lactate concentration (latest prior to randomisation). Additionally, we will perform separate assessments of the treatment effect interaction with each of the baseline parameters above on the continuous scale and present these using conditional effects plots. Conclusions This secondary analysis will aid the interpretation of the HOT‐ICU trial by evaluating probabilities of all effect sizes. In addition, we will evaluate whether HTE is present, thus, further evaluating benefits and harms of a lower versus a higher oxygenation target in adult ICU patients with acute hypoxaemic respiratory failure.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Bayesian and heterogeneity of treatment effect analyses of the HOT‐ICU trial—A secondary analysis protocol

Klitgaard

Schjørring

Lange

et al. 2020

Acta Anaesthesiol Scand

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“…The oxygenation levels in patients admitted to intensive care units (ICUs) worldwide differ extensively . Several randomised clinical trials investigating the effects of a higher vs a lower oxygenation strategy for patients admitted to the ICU have been published throughout the last 5 years, the results, however, remain inconclusive . We present a detailed statistical analysis plan of the to date largest and still ongoing randomised clinical trial of higher vs lower oxygenation targets in the ICU, the handling oxygenation targets in the intensive care unit (HOT‐ICU) trial.…”

Section: Introductionmentioning

confidence: 99%

The handling oxygenation targets in the intensive care unit (HOT‐ICU) trial: Detailed statistical analysis plan

Schjørring

Klitgaard

Perner

et al. 2020

Acta Anaesthesiol Scand

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Background No solid evidence exists on optimal oxygenation targets in intensive care patients. The handling oxygenation targets in the intensive care unit (HOT‐ICU) trial assesses the effects of a targeted arterial oxygen tension of 8 vs 12 kPa on 90‐day mortality in acutely admitted adult patients with hypoxaemic respiratory failure. This article describes the detailed statistical analysis plan for the predefined outcomes and supplementary analyses in the HOT‐ICU trial. Methods The trial will include 2928 patients to be able to detect or reject a true 20% relative risk reduction in the primary outcome of 90‐day all‐cause mortality with an α of 5% and a β of 10%. Analyses of the primary and secondary outcomes will be conducted according to the intention‐to‐treat principle and adjusted for stratification variables. The primary outcome and dichotomous secondary outcomes will be analysed using a generalised linear model with a log‐link and binomial error distribution. For the primary outcome, a 95% confidence interval (CI) not including 1.00 for the risk ratio will be considered statistically significant. Continuous secondary outcomes will be analysed using a generalised linear model or nonparametric test. CIs adjusted for the multiple secondary outcomes not including the null effect will be considered statistically significant. One planned interim analysis has been conducted. Conclusions The HOT‐ICU trial and the pre‐planned statistical analyses are designed to minimise bias and produce high quality data on the effects of a lower vs a higher oxygenation target throughout ICU admission in acutely admitted adult patients with hypoxaemic respiratory failure. Registration ClinicalTrials.gov identifier: NCT03174002, date of registration: June 2, 2017. European clinical trials database, EudraCT number 2017‐000632‐34.

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“…In addition, a meta-regression effect of SpO 2 on in-hospital mortality showed an increased SpO 2 was associated with an increased risk of mortality. Barbateskovic et al [ 57 ] subsequently conducted another meta-analysis to evaluate the benefits and harms of higher versus lower F I O 2 or target PaO 2 in adult patients in ICU. They included a total of 10 RCTs with 1458 patients, and demonstrated that lower F I O 2 or target PaO 2 was associated with a marginal increase in the risk of mortality.…”

Section: Oxygen Concentration and Oxygen Toxicitymentioning

confidence: 99%

Oxygen administration for patients with ARDS

Ohshimo

2021

j intensive care

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Acute respiratory distress syndrome (ARDS) is a fatal condition with insufficiently clarified etiology. Supportive care for severe hypoxemia remains the mainstay of essential interventions for ARDS. In recent years, adequate ventilation to prevent ventilator-induced lung injury (VILI) and patient self-inflicted lung injury (P-SILI) as well as lung-protective mechanical ventilation has an increasing attention in ARDS.Ventilation-perfusion mismatch may augment severe hypoxemia and inspiratory drive and consequently induce P-SILI. Respiratory drive and effort must also be carefully monitored to prevent P-SILI. Airway occlusion pressure (P0.1) and airway pressure deflection during an end-expiratory airway occlusion (Pocc) could be easy indicators to evaluate the respiratory drive and effort. Patient-ventilator dyssynchrony is a time mismatching between patient’s effort and ventilator drive. Although it is frequently unrecognized, dyssynchrony can be associated with poor clinical outcomes. Dyssynchrony includes trigger asynchrony, cycling asynchrony, and flow delivery mismatch. Ventilator-induced diaphragm dysfunction (VIDD) is a form of iatrogenic injury from inadequate use of mechanical ventilation. Excessive spontaneous breathing can lead to P-SILI, while excessive rest can lead to VIDD. Optimal balance between these two manifestations is probably associated with the etiology and severity of the underlying pulmonary disease.High-flow nasal cannula (HFNC) and non-invasive positive pressure ventilation (NPPV) are non-invasive techniques for supporting hypoxemia. While they are beneficial as respiratory supports in mild ARDS, there can be a risk of delaying needed intubation. Mechanical ventilation and ECMO are applied for more severe ARDS. However, as with HFNC/NPPV, inappropriate assessment of breathing workload potentially has a risk of delaying the timing of shifting from ventilator to ECMO. Various methods of oxygen administration in ARDS are important. However, it is also important to evaluate whether they adequately reduce the breathing workload and help to improve ARDS.

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Higher versus lower fraction of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit

Abstract: Analysis 2.5. Comparison 2 Sensitivity analysis: all-cause mortality-at maximum follow-up, Outcome 5 All-cause mortality-at maximum follow-up-types of oxygen interventions.

Cited by 63 publications

References 140 publications

Bayesian and heterogeneity of treatment effect analyses of the HOT‐ICU trial—A secondary analysis protocol

Bayesian and heterogeneity of treatment effect analyses of the HOT‐ICU trial—A secondary analysis protocol

The handling oxygenation targets in the intensive care unit (HOT‐ICU) trial: Detailed statistical analysis plan

Oxygen administration for patients with ARDS

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