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

Phase 4

Conditions: lichamelijk trauma na ongeval
Injury
Trauma
10022114

Registration Number: NL-OMON53478

Lead Sponsor: Rigshospitalet Kopenhaben

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 275

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

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 <24 hours
4) Insufficient comprehension of Dutch language (also applies to person
providing proxy consent)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be a combined endpoint of 30-day mortality<br /><br>and/or major respiratory complications (pneumonia and ARDS) within 30 days. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures will be mortality at 30 days and 12 months after<br /><br>trauma, major respiratory complications (pneumonia and ARDS) within 30 days,<br /><br>hospital length of stay (HLOS), Intensive Care Unit length of stay (ICU LOS)<br /><br>and days alive outside the ICU, time on mechanical ventilation (until 30 days),<br /><br>days alive without mechanical ventilation and number of re-intubations within<br /><br>30 days, pneumonia post-discharge within 30 days, episodes of hypoxaemia during<br /><br>intervention (saturation <90%), surgical site infections within 30 days,<br /><br>EQ-5D-5L score at 6 months and 12 months post-trauma, and GOSE score at 6<br /><br>months and 12 months post-trauma.</p><br>