Clinical Summary | Critical Care, Anaesthetics & Emergency Medicine
Early Restrictive vs Liberal Oxygen for Trauma Patients The TRAUMOX2 Randomized Clinical Trial
Time to read: 06:26
Time to listen: 10:54
Published on MedED: 15 January 2025
Originally Published: 10 December 2024
Source: JAMA
Type of article: Clinical Research Summary
MedED Catalogue Reference: MCECS015
Category: Critical Care, Anaesthetics & Emergency Medicine
Cross-reference: Neurology, Surgery
Keywords: trauma, liberal oxygen therapy
Originally Published in JAMA,10 December 2024. This is a summary of the clinical study and in no way represents the original research. Unless otherwise indicated, all work contained here is implicitly referenced to the original author and trial. Links to all original material can be found at the end of this summary. Access the Disclaimer
Key Take Aways
1. The study suggests that restrictive oxygen therapy for trauma patients did not significantly reduce death or major respiratory complications.
2. While the findings may not be directly applicable to all settings, targeting normoxia (SpO2 94-98%) in the early phase remains a reasonable approach for managing moderate to severe trauma cases
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Study Context | Objectives | Study Design | Findings | Discussion| Limitations | Conclusion | Original Research | Funding | References
Trauma continues to be a major global health issue, contributing significantly to morbidity and mortality worldwide. Each year, trauma is responsible for an alarming 4.4 million deaths, with 90% of these fatalities occurring in low- and middle-income countries. This issue places immense strain on healthcare systems, as well as on economies across the globe. Addressing this growing challenge has become an urgent priority for governments and public health organisations worldwide.1
In the context of trauma care, the Advanced Trauma Life Support (ATLS) guidelines recommend the administration of supplemental oxygen for severely injured patients in the initial period following injury.
However, hypoxaemia, or excess oxygen in the bloodstream, is a commonly observed phenomenon in trauma patients. Despite its prevalence, there is a lack of substantial evidence to support the widespread use of liberal oxygen therapy in these cases. While oxygen targets have been thoroughly explored in intensive care unit (ICU) populations, there remains a gap in the literature regarding the optimal oxygen management strategies for trauma patients specifically. Addressing this gap is crucial to improving outcomes and reducing the burden of trauma on healthcare systems
Recent evidence has raised concerns about the potential risks associated with liberal oxygen treatment, particularly its association with increased mortality rates and respiratory complications.
The primary objective of this study was to evaluate the efficacy of a restrictive oxygen strategy compared to a liberal oxygen strategy in reducing death or major respiratory complications in adult trauma patients.
The study aimed to determine if limiting oxygen treatment during the first 8 hours post-injury would lead to better patient outcomes, such as lower mortality and fewer respiratory complications, within 30 days.
The study was registered as ClinicalTrials.gov Identifier: NCT05146700
The multi-centre, randomised, controlled trial included adult trauma patients who were directly transferred to hospital and who had an anticipated hospital stay of at least 24 hours.
The trial was conducted across 15 prehospital bases and five major trauma centres in Denmark, the Netherlands, and Switzerland from December 2021 to September 2023.
A total of 1,457 patients were enrolled and randomised in a 1:1 ratio into either a restrictive oxygen strategy group (targeting an arterial oxygen saturation of 94%) or a liberal oxygen strategy group (administering 12-15 L of oxygen per minute or a fraction of inspired oxygen between 0.6-1.0).
The intervention period lasted for 8 hours from the time of trauma centre admission or during the prehospital phase.
Primary Outcomes: Patients were followed for 30 days, and the primary outcome was a composite of death and/or major respiratory complications.
Secondary outcomes: Death and major respiratory complications assessed individually, were also analysed.
A total of 1,508 patients (733 in the restrictive oxygen group and 724 in the liberal oxygen group) were included in the study.
The average age of participants was 50 years, with 73% being male, and the median Injury Severity Score was 14.
The findings were as follows:
Within 30 days, 118 (16.1%) patients in the restrictive oxygen group and 121 (16.7%) patients in the liberal oxygen group experienced the composite primary outcome (death and/or major respiratory complications).
The odds ratio for the restrictive group compared to the liberal group was 1.01, indicating no significant difference between the two strategies (P = 0.94; absolute difference, 0.56 percentage points [95% CI, −2.70 to 3.82]).
There were no notable differences in the individual components of the primary outcome between the two groups.
The rates of adverse events were similar across both groups, except for atelectasis, which occurred less frequently in the restrictive oxygen group (27.6%) compared to the liberal group (34.7%).
The study findings indicate that, in adult trauma patients, an early restrictive oxygen strategy when compared to a liberal oxygen strategy, did not result in significant differences in the composite outcome of death and/or major respiratory complications within 30 days.
The absence of any substantial difference suggests that a restrictive oxygen strategy may not provide superior outcomes in this patient population.
Furthermore, the study highlights that while adverse events were similar between groups, the restrictive oxygen strategy was associated with a lower incidence of atelectasis, suggesting a potential benefit in reducing this specific respiratory complication.
Some researchers, however, have urged caution in interpreting the results, citing a few key concerns one of which is that an eight-hour period of observation may be insufficient to detect a meaningful effect, as damage caused by hyperoxia has been observed to occur upto 12 hours in animal models.
Additionally, it has been pointed out that 60% of patients in the restrictive oxygen group were randomised in-hospital, and although the median duration of supplemental oxygen prior to randomisation was relatively brief (30 minutes, IQR 15–53), this prior exposure could introduce a contamination bias.
Finally, the findings may not be fully generalisable to all healthcare settings, particularly in low- and middle-income countries where healthcare infrastructure and patient management strategies can differ significantly.
Conclusion
This randomised controlled trial provides valuable insights into the management of oxygen therapy in trauma patients.
The results suggest that an early restrictive oxygen strategy, implemented during the first 8 hours post-trauma, does not significantly reduce death and/or major respiratory complications when compared to a liberal oxygen strategy. These findings contribute to the growing body of evidence questioning the benefits of liberal oxygen treatment and may guide future practices in the management of oxygenation in trauma patients. Further research is needed to explore other potential strategies for optimising oxygen therapy in this patient population.
Importance of this study for South Africa
In South Africa, trauma is a critical public health issue, accounting for 10% of all-cause mortality. At 157.8 per 100,000 people, the local trauma-related mortality rate surpasses the African continent's average rate of 139.5 per 100,000.1,2 When compared to global averages, the nation's rates of road traffic-related deaths occur at twice the global rate, with homicide mortality eight times greater.
A recent 2024 study conducted in the Western Cape, which looked into the incidence of preventable trauma deaths in the province, found that 33% of the reviewed deaths were either preventable or potentially preventable. These preventable deaths were more frequently associated with late-stage complications, such as multi-organ failure and sepsis, which occurred in 56% of cases, compared to early deaths (within 24 hours), where central nervous system injury and haemorrhage accounted for 63% of non-preventable fatalities.1
This study was of interest as it aimed to determine whether a restrictive oxygen strategy could improve patient outcomes, including reduced mortality and fewer respiratory complications, thereby preventing excess deaths. While the findings did not support this, the results may not be generalisable to our healthcare settings, given the study was conducted in Denmark and Switzerland. Nevertheless, targeting normoxia (SpO2 94-98%) in the early phase for patients with moderate to severe trauma appears reasonable.
This data underscores the critical importance of developing and implementing effective strategies to reduce preventable trauma deaths and improve patient outcomes.
Additionally, such strategies are essential to alleviating the burden on South Africa's healthcare system, ensuring the sustainability of services, and ultimately saving lives.
Access the Study
Arleth, T., Baekgaard, J., Siersma, V., Creutzburg, A., Dinesen, … TRAUMOX2 Trial Group (2024). Early Restrictive vs Liberal Oxygen for Trauma Patients: The TRAUMOX2 Randomized Clinical Trial. JAMA, 10.1001/jama.2024.25786. Advance online publication. https://doi.org/10.1001/jama.2024.25786
Conflict of Interest, Funding and Support
Role of the Funder/Sponsor
The study's funder had no role in the design, data collection, data analysis, data interpretation, or writing of the report.
Conflict of Interest Disclosures
None declared
Funding/Support
Rigshospitalet, Denmark
References
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