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: 20.0 Level: PT
Conditions
Interventions
Trade Name: Oxygen
Pharmaceutical Form: Medicinal gas, compressed
INN or Proposed INN: OXYGEN
Other descriptive name: OXYGEN
Concentration unit: % percent
Concentration type: range
Concentration numbe
Sponsors
Rigshospitalet, Department of Anaesthesia, Centre of Head and Orthopaedics
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial, TRAUMOX2, will be to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours after trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined endpoint).;Secondary Objective: To assess mortality at 30 days and 12 months after trauma, major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days, hospital length of stay (HOS LOS), ICU length of stay (ICU LOS), days alive outside the ICU, time on mechanical ventilation (until 30 days), days alive without mechanical ventilation, number of re-intubations within 30 days, pneumonia post-discharge within 30 days, episodes with hypoxaemia during intervention (saturation <90%), surgical site infections within 30 days, EQ-5D-5L score and GOSE score at 6 months and 12 months post-trauma.;Primary end point(s): The incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined endpoint).;Timepoint(s) of evaluation of this end point: 30 days after after trauma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mortality at 30 days and 12 months after trauma - Major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days - Hospital length of stay, intensive care unit (ICU) length of stay and days alive outside the ICU - Time on mechanical ventilation (until 30 days), days alive without mechanical ventilation and re-intubation within 30 days - Pneumonia post-discharge within 30 days - Episodes of hypoxaemia during intervention (saturation <90%) - Surgical site infections within 30 days - EQ-5D-5L score at 6 and 12 months post-trauma - GOSE score at 6 months and 12 months post-trauma;Timepoint(s) of evaluation of this end point: 30 days, 6 months and 12 months after trauma. | — |
Countries
Denmark, Finland, France, Germany, Netherlands
Contacts
Public ContactTobias Arleth
Rigshospitalet, Department of Anaesthesia, Centre of Head and Orthopaedics
Outcome results
None listed