CompletedPhase 4

Restrictive Vs. Liberal Oxygen in Trauma

Denmark, Netherlands, Switzerland1,508 participantsStarted 2021-12-10

Plain-language summary

Victims of trauma are often healthy individuals prior to the incident, but acquire numerous complications including sepsis and pulmonary complications and diminished quality of life after trauma. According to Advanced Trauma Life Support guidelines, all severely injured trauma patients should receive supplemental oxygen. The objective of TRAUMOX2 is to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours following trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined primary endpoint).

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Patients aged ≥18 years, including fertile women * Blunt or penetrating trauma mechanism * Direct transfer from the scene of accident to one of the participating trauma centers * Trauma team activation * The enrolling physician must initially expect a hospital length of stay for 24 hours or longer Exclusion Criteria: * Patients in cardiac arrest before or on admission * Patients with a suspicion of carbon monoxide intoxication * Patients with no/minor injuries after secondary survey will be excluded if they are expected to be discharged \<24 hours

What they're measuring

The incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined primary endpoint)

Timeframe: Day 30 after enrollment

Trial details

NCT IDNCT05146700

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-12

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