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Comparing Restrictive vs. Liberal Oxygen Strategies for Trauma Patients: The TRAUMOX2 Trial

Comparing Restrictive vs. Liberal Oxygen Strategies for Trauma Patients: The TRAUMOX2 Trial - TRAUMOX2

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53478
Enrollment
275
Registered
2021-12-20
Start date
2022-05-18
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lichamelijk trauma na ongeval Injury Trauma

Interventions

Restrictive (intervention) versus liberal (control) oxygen treatment.

Sponsors

Rigshospitalet Kopenhaben
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Patients aged >=18 years, including fertile women* 2) Blunt or penetrating trauma mechanism 3) Direct transfer from the scene of accident to one of the participating trauma centres 4) Trauma team activation (basic or extended trauma team) 5) The enrolling physician must initially expect a hospital length of stay for 24 hours or longer 6) Deferred consent by patient or proxy

Exclusion criteria

Exclusion criteria: 1) Patients in cardiac arrest before or on admission 2) Patients with a suspicion of carbon monoxide intoxication 3) Patients with no/minor injuries after secondary survey will be excluded if they are expected to be discharged

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be a combined endpoint of 30-day mortality and/or major respiratory complications (pneumonia and ARDS) within 30 days.

Secondary

MeasureTime frame
The secondary outcome measures will be mortality at 30 days and 12 months after trauma, major respiratory complications (pneumonia and ARDS) within 30 days, hospital length of stay (HLOS), Intensive Care Unit length of stay (ICU LOS) and days alive outside the ICU, time on mechanical ventilation (until 30 days), days alive without mechanical ventilation and number of re-intubations within 30 days, pneumonia post-discharge within 30 days, episodes of hypoxaemia during intervention (saturation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026