Victims of trauma are often healthy individuals prior to the incident, but acquire numerous complications including sepsis and pulmonary complications as well as long-term complications and diminished quality of life after the trauma. Understanding the reasons behind these complications and poor outcomes and optimizing care is therefore essential to increase survival rates and quality of life MedDRA version: 20.0 Level: LLT Classification code 10050322 Term: Oxygen supplementation System Organ
Conditions
Interventions
Trade Name: Oxygen
Pharmaceutical Form: Medicinal gas, compressed
INN or Proposed INN: OXYGEN
Concentration unit: % percent
Concentration type: range
Concentration number: 0-100
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria - Age = 18 years, including fertile women* - Blunt/Penetrating trauma patient - Direct transfer from the scene of the accident to Rigshospitalets Traume Center - Trauma team activation * 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exclusion Criteria - Patients in cardiac arrest before/at admission - Patients with a suspicion of smoke inhalation - No hospital admission after initial treatment in trauma center
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate whether the maintenance of pragmatic normoxia, avoiding both hyperoxic and hypoxic phases, is feasible within the first 24 hours after trauma, as it may result in a reduction of 30-day mortality and major respiratory complications within 30 days (respiratory failure, pulmonary edema, and pneumonia). We will conduct a pilot study, where 40 patients are randomized to 24 hours of: A. Restrictive, but sufficient oxygen treatment: lowest oxygen delivery that obtains a saturation of = 94% B. Liberal oxygen treatment: 15 L/min oxygen flow initially/ FiO2 =0.8 A. within the low limits of standard of care and does not put patients at risk of receiving worse treatment. B. as close as possible to the standard of care. As no precise guidelines on oxygen delivery for trauma patients within the first 24 hours exist, this will however inevitably vary in practice. ;Secondary Objective: Not applicable;Primary end point(s): Composite Primary Outcomes: 30-day mortality and major respiratory complications within 30 days (pneumonia, acute respiratory distress syndrome (ARDS), acute lung injury (ALI)). ;Timepoint(s) of evaluation of this end point: Any time before hospital discharge (but within 30 days) and after 30 days of trauma | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Outcomes • Intensive Care Unit length of stay (ICU LOS) • Hospital length of Stay • Days on ventilator • Within 30 days post trauma (through telephone follow-up if discharged) o Sepsis o Surgical Site Infection (SSI) • 30 days post-trauma (through telephone follow-up if discharged) o Glasgow Outcome Scale Extended (GOSE) ;Timepoint(s) of evaluation of this end point: Any time before hospital discharge (but within 30 days) and after 30 days of trauma | — |
Countries
Denmark
Outcome results
None listed