Early Restrictive vs Liberal Oxygen for Trauma Patients: The TRAUMOX2 Randomized Clinical Trial

Tobias Arleth, MD1; Josefine Baekgaard, MD, PhD1; Volkert Siersma, PhD2; et al

2024년 12월 10일

JAMA. 2025;333(6):479-489. doi:10.1001/jama.2024.25786

Published online December 10, 2024.

Abstract

Importance 

Early administration of supplemental oxygen for all severely injured trauma patients is recommended, but liberal oxygen treatment has been associated with increased risk of death and respiratory complications.

Objective 

To determine whether an early 8-hour restrictive oxygen strategy compared with a liberal oxygen strategy in adult trauma patients would reduce death and/or major respiratory complications.

Design, Setting, and Participants 

This randomized controlled trial enrolled adult trauma patients transferred directly to hospitals, triggering a full trauma team activation with an anticipated hospital stay of a minimum of 24 hours from December 7, 2021, to September 12, 2023. This multicenter trial was conducted at 15 prehospital bases and 5 major trauma centers in Denmark, the Netherlands, and Switzerland. The 30-day follow-up period ended on October 12, 2023. The primary outcome was assessed by medical specialists in anesthesia and intensive care medicine blinded to the randomization.

Intervention 

In the prehospital setting or on trauma center admission, patients were randomly assigned 1:1 to a restrictive oxygen strategy (arterial oxygen saturation target of 94%) (n = 733) or liberal oxygen strategy (12-15 L of oxygen per minute or fraction of inspired oxygen of 0.6-1.0) (n = 724) for 8 hours.

Main Outcomes and Measures 

The primary outcome was a composite of death and/or major respiratory complications within 30 days. The 2 key secondary outcomes, death and major respiratory complications within 30 days, were assessed individually

Results 

Among 1979 randomized patients, 1508 completed the trial (median [IQR] age, 50 [31-65] years; 73% male; and median Injury Severity Score was 14 [9-22]). Death and/or major respiratory complications within 30 days occurred in 118 of 733 patients (16.1%) in the restrictive oxygen group and 121 of 724 patients (16.7%) in the liberal oxygen group (odds ratio, 1.01 [95% CI, 0.75 to 1.37]; P = .94; absolute difference, 0.56 percentage points [95% CI, −2.70 to 3.82]). No significant differences were found between groups for each component of the composite outcome. Adverse and serious adverse events were similar across groups, with the exception of atelectasis, which was less common in the restrictive oxygen group compared with the liberal oxygen group (27.6% vs 34.7%, respectively).

Conclusions and Relevance 

In adult trauma patients, an early restrictive oxygen strategy compared with a liberal oxygen strategy initiated in the prehospital setting or on trauma center admission for 8 hours did not significantly reduce death and/or major respiratory complications within 30 days.

Trial Regristration

ClinicalTrials.gov Identifier: NCT05146700

Key Points

Question  Does an early, 8-hour restrictive oxygen strategy compared with a liberal oxygen strategy in severely injured trauma patients reduce mortality and/or major respiratory complications?

Findings  Among 1508 randomized adult trauma patients, no difference was found in death and/or major respiratory complications within 30 days among patients in the restrictive oxygen group compared with those in the liberal oxygen group (16.1% vs 16.7%, respectively).

Meaning  In severely injured trauma patients, an early restrictive oxygen strategy compared with a liberal oxygen strategy initiated in the prehospital setting or on trauma center admission did not significantly reduce mortality and/or major respiratory complications.

요약

• 소개 : 심하게 손상된 외상 환자에게 초기 보조 산소 투여가 권장되지만, 과도한 산소 치료는 사망률 증가와 호흡 합병증의 위험을 높이는 것으로 알려져 있다. 본 연구는 외상 환자에게 병원 전 단계에서부터 8시간 동안 제한적 산소 전략(산소포화도 목표 94%)을 적용하는 것이 개방적인 산소 전략(12-15L/분 또는 FiO₂ 0.6-1.0)에 비해 30일 내 사망률 및 주요 호흡 합병증을 줄이는가를 평가하는 것을 목표로 한다.

  
  

• 방법 : 2021년 12월 7일부터 2023년 9월 12일까지 덴마크, 네덜란드, 스위스의 15개 병원 전 기지 및 5개 주요 외상 센터에서 성인 외상 환자를 대상으로 무작위 대조 시험을 진행하였다. 총 1979명이 등록되었으며, 최소 24시간 이상의 입원이 예상되는 중증 외상 환자를 제한적 산소 전략군(733명)과 개방적 산소 전략군(724명)으로 1:1 무작위 배정하였다. 주요 임상 결과는 마취 및 중환자의학 전문의가 평가한 30일 내 사망 및/또는 주요 호흡 합병증 발생 여부이다.

• 결과 : 제한적 산소 전략군에서 118명(16.1%), 개방적 산소 전략군에서 121명(16.7%)이 30일 내 사망 및 주요 호흡 합병증을 경험하였으며, 두 군 간 유의미한 차이는 없었다(OR 1.01; 95% CI 0.75-1.37; P = .94). 단, 무기폐(atelectasis) 발생률은 제한적 산소군이 개방적 산소군보다 낮게 나타났다(27.6% vs 34.7%).

  
  

• 결론 및 의의 : 병원 전 단계나 외상 센터 도착 시점부터 8시간 동안 제한적 산소 전략을 적용하더라도 개방적 산소 전략에 비해 30일 내 사망률 및 주요 호흡 합병증 발생률을 유의미하게 감소시키지 못한다.