Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial
Open accessAbstract
Importance: Despite suggestions of potential harm from unnecessary oxygen therapy, critically ill patients spend substantial periods in a hyperoxemic state. A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice. Objective: To assess whether a conservative protocol for oxygen supplementation could improve outcomes in patients admitted to intensive care units (ICUs). Design, Setting, and Patients: Oxygen-ICU was a single-center, open-label, randomized clinical trial conducted from March 2010 to October 2012 that included all adults admitted with an expected length of stay of 72 hours or longer to the medical-surgical ICU of Modena University Hospital, Italy. The originally planned sample size was 660 patients, but the study was stopped early due to difficulties in enrollment after inclusion of 480 patients. Interventions: Patients were randomly assigned to receive oxygen therapy to maintain Pao2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation (Spo2) between 94% and 98% (conservative group) or, according to standard ICU practice, to allow Pao2 values up to 150 mm Hg or Spo2 values between 97% and 100% (conventional control group). Main Outcomes and Measures: The primary outcome was ICU mortality. Secondary outcomes included occurrence of new organ failure and infection 48 hours or more after ICU admission. Results: A total of 434 patients (median age, 64 years; 188 [43.3%] women) received conventional (n = 218) or conservative (n = 216) oxygen therapy and were included in the modified intent-to-treat analysis. Daily time-weighted Pao2 averages during the ICU stay were significantly higher (P < .001) in the conventional group (median Pao2, 102 mm Hg [interquartile range, 88-116]) vs the conservative group (median Pao2, 87 mm Hg [interquartile range, 79-97]). Twenty-five patients in the conservative oxygen therapy group (11.6%) and 44 in the conventional oxygen therapy group (20.2%) died during their ICU stay (absolute risk reduction [ARR], 0.086 [95% CI, 0.017-0.150]; relative risk [RR], 0.57 [95% CI, 0.37-0.90]; P = .01). Occurrences were lower in the conservative oxygen therapy group for new shock episode (ARR, 0.068 [95% CI, 0.020-0.120]; RR, 0.35 [95% CI, 0.16-0.75]; P = .006) or liver failure (ARR, 0.046 [95% CI, 0.008-0.088]; RR, 0.29 [95% CI, 0.10-0.82]; P = .02) and new bloodstream infection (ARR, 0.05 [95% CI, 0.00-0.09]; RR, 0.50 [95% CI, 0.25-0.998; P = .049). Conclusions and Relevance: Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy vs conventional therapy resulted in lower ICU mortality. These preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of this approach. Trial Registration: clinicaltrials.gov Identifier: NCT01319643.
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The evidence for the use of conservative oxygen targets and therapy in patients with sepsis is limited, with three randomised trials in the critically ill population.
“The evidence for the use of conservative oxygen targets (generally defined as PaO2 55–70 mmHg; SpO2 88–92%) and therapy in patients with sepsis is limited, with three randomised trials in the critically ill population [404–406].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [404]
In that previous single-centre trial, conservative oxygen therapy in the ICU was associated with a markedly lower rate of death than usual oxygen therapy.
“In that trial, conservative oxygen therapy in the ICU was associated with a markedly lower rate of death than usual oxygen therapy [404].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [404]
Examining interim outcome data can bias trial results and interpretation and introduce analytical and ethical challenges when interim analyses are not prespecified or lead to early study termination.
“Examining interim outcome data can bias trial results and interpretation and introduce analytical and ethical challenges when interim analyses are not prespecified or lead to early study termination.”
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- Authors
- Girardis, M., Busani, S., Damiani, E., Donati, A., Rinaldi, L., Marudi, A., Morelli, A., Antonelli, M., & Singer, M.
- Affiliations
- Azienda Ospedaliero-Universitaria di Modena (IT)
- Marche Polytechnic University (IT)
- Intensive Care Unit, Department of Anaesthesiology and Intensive Care, NOCSAE Hospital, Modena, Italy
- Sapienza University of Rome (IT)
- Università Cattolica del Sacro Cuore (IT)
- University College London (GB)
- Corresponding author
- Girardis, Massimo
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2016-10-18
- Volume
- 316
- Issue
- 15
- Pages
- 1583
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2528556615
- Cited by
- 723
- References
- 35
- Citations by year
- 2026: 34 · 2025: 58 · 2024: 61 · 2023: 66 · 2022: 89 · 2021: 105 · 2020: 97 · 2019: 59 · 2018: 73 · 2017: 75 · 2016: 4 · 2015: 1
- FWCI
- 63.04
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Università Politecnica delle Marche (Università Politecnica delle Marche) (submittedVersion)
- Funders
- Università Degli Studi di Modena e Reggio Emila
- InflaRx
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Nosocomial Infections in ICU
- Keywords
- conservative oxygen therapy, hyperoxemia, arterial oxygenation, ICU mortality, critically ill patients, supplemental oxygen, arterial oxygen partial pressure, oxygen saturation, organ failure, infection, mechanical ventilation, intensive care unit admission criteria
- MeSH terms
- Adult, Aged, Cross Infection, Female, Humans, Intensive Care Units, Length of Stay, Male, Middle Aged, Oxygen, Oxygen Inhalation Therapy, Partial Pressure, Shock, Critical Illness, Hospital Mortality, Liver Failure, Hyperoxia, Early Termination of Clinical Trials
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