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

Phase 1

• Conditions: 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. We wish to optimize the oxygen treatment and look at the patients' 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days after being allocated to either an 8 hour liberal or restrictive oxygen strategy.; MedDRA version: 20.0Level: PTClassification code 10033316Term: Oxygen saturationSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.0Level: LLTClassification code 10050322Term: Oxygen supplementationSystem Organ Class: 100000004865; MedDRA version: 20.0Level: LLTClassification code 10033323Term: Oxygen tensionSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.0Level: LLTClassification code 10033324Term: Oxygen tension abnormal NOSSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.0Level: LLTClassification code 10033325Term: Oxygen tension decreasedSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.0Level: LLTClassification code 10033326Term: Oxygen tension increasedSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.0Level: LLTClassification code 10033327Term: Oxygen tension normalSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.1Level: LLTClassification code 10068430Term: Arterial oxygen saturationSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.1Level: LLTClassification code 10068431Term: Arterial oxygen saturation increasedSystem Organ Class: 10022891 - Investigations

• Registration Number: EUCTR2021-000556-19-DK
• Lead Sponsor: Rigshospitalet, Department of Anaesthesia, Centre of Head and Orthopaedics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-15
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

- Age =18 years, including fertile women*
- Blunt/penetrating trauma mechanism
- Direct transfer from the scene of accident to one of the participating trauma centres
- Trauma team activation
- The enrolling physician must initially expect a hospital length of stay for 24 hours or longer

*There is no added risk for enrolment of fertile women as oxygen administration is approved for this group of patients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1040
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 560

Exclusion Criteria

- Patients in cardiac arrest before/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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified