At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparing Restrictive Vs. Liberal Oxygen Strategies for Trauma Patients: the TRAUMOX2 Trial
In Brief
A Phase 4 clinical trial evaluating Restrictive oxygen and Liberal oxygen for Trauma and 2 related conditions. Completed, enrolled 1,508 participants across 5 sites in 3 countries.
Detailed Summary
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. According to Advanced Trauma Life Support guidelines, all severely injured trauma patients should receive supplemental oxygen. The objective of TRAUMOX2 is to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours following trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined primary endpoint).
Study Details
Timeline
Interventions
Lowest oxygen delivery possible (≥21%) ensuring an SpO2 target = 94%
15 L O2/min flow for non-intubated trial participants or FiO2 = 1.0 for intubated trial participants in the initial phase; later in the operating room, intensive care unit, post-anesthesia care unit and ward, the flow/FiO2 can be reduced to ≥12 L O2/min or FiO2 ≥0.6 if the arterial oxygen saturation is ≥98%