NCT04534972

Strategy to Avoid Excessive Oxygen in Major Burn Patients

Strategy to Avoid Excessive Oxygen in Major Burn Patients (SAVE-O2)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in major burn patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

Detailed description

Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxemia. Although routine, the practice of excessive over-oxygenation may be harmful. An expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (SpO2) range of 90-96%, an arterial oxygen (PaO2) range of 60-100 mmHg (when applicable), and a fraction of inspired oxygen (FiO2) of 21% for mechanically ventilated patients or room air for nonmechanically ventilated patients. Specific Aim: The purpose of this study is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in major burn patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy. Hypotheses: Clinical efforts to through a multimodal educational intervention will: 1. Improve the proportion of time spent within target normoxemia thresholds (oxygen saturation \[SpO2\] 90-96% and/or arterial oxygen \[PaO2\] 60-100 mmHg \[when applicable\]) 2. Limiting use of excessive supplemental oxygen 3. Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects

Conditions

• Critical Illness
• Wounds and Injury
• Disease Attributes
• Pathologic Processes

Interventions

Type	Name	Description
OTHER	Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)	Post-implementation of targeted normoxemia through oxygen titration for individual patients. Intervention for treatment of hypoxemia will follow usual local practice. Interventions for treatment of hyperoxemia (SpO2 \>96% or PaO2 \> 100 mmHg) will involve down titration of FiO2 (or supplemental oxygen for non-mechanically ventilated patients) within a time frame based on local site preferences-typically in increments of no greater than 0.10 until goal oxygenation in the normoxemia range is achieved (including room air \[no supplemental oxygen\] for non-mechanically ventilated patients).

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-11-15
• Completion: 2025-12-31
• First posted: 2020-09-01
• Last updated: 2025-04-02

Locations

6 sites across 1 country: United States