study information

Comparing Restrictive vs. Liberal Oxygen Strategies for Trauma Patients: The TRAUMOX2 Trial is an international, multicentre, parallel-grouped, superiority, primary outcome assessor- and analyst-blinded, randomized, controlled clinical trial. It is carried out in three different countries in the continental Europe (Denmark, The Netherlands and Switzerland) in five different trauma centre sites (see trial sites).

The primary objective of TRAUMOX2 is to compare the effect of a restrictive oxygen strategy versus a liberal oxygen strategy the first eight hours after trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and/or acute respiratory distress syndrome) within 30 days (composite endpoint). We hypothesise that the restrictive strategy compared to the liberal strategy will result in a significant lower incidence of the composite outcome.

Patients are screened for eligibility in the prehospital phase or the trauma centre depending on the possibilities at the including trial site. A patient must fulfill the following inclusion criteria to be included in the study:

  • Age ≥18 years
  • Blunt/penetrating trauma mechanism
  • Direct transfer from the scene of accident to one of the participating trauma centres
  • Trauma team activation at the trauma centre
  • The enrolling physician must initially expect a hospital length of stay for 24 hours or longer

See the scheme overview for the intervention and outcomes below. Patients will be evaluated at 30 days, 6 months and 12 months days according to the primary and secondary outcomes. The trial will stop including when 710 patients are included in each arm with a complete 30-day follow-up, yielding a total of 1420 patients.

Please see our animated video on how to enrol and manage trial interventions of trial participants in TRAUMOX2 on the front page of this site.

For further details on the study, please see the study protocol in the study documents page. number: NCT05146700
EudraCT number: 2021-000556-19

Intervention and outcomes scheme overview

O2: Oxygen; FiO2: Fraction of Inspired Oxygen; SpO2: Peripheral Saturation of Oxygen (pulse oximetry); OR: Operating Room; ICU: Intensive Care Unit; PACU: Post-Anaesthesia Care Unit

ARDS: Acute Respiratory Distress Syndrome; LOS: Length of Stay; HOS: Hospital; EQ-5D-5L (see website and trial document) GOSE: Glasgow Outcome Scale Extended (see trial document)