Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Critical Illness
  • Disease Attributes
  • Pathologic Processes
  • Wounds and Injury
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 120 years
Gender
Both males and females

Description

Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxia. Although routine, the practice of excessive over-oxygenation may be harmful. An expert panel was convened and developed the strong consensus to target normoxia at an...

Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxia. Although routine, the practice of excessive over-oxygenation may be harmful. An expert panel was convened and developed the strong consensus to target normoxia 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: Improve the proportion of time spent within target normoxia thresholds (oxygen saturation [SpO2] 90-96% and/or arterial oxygen [PaO2] 60-100 mmHg [when applicable]) Limiting use of excessive supplemental oxygen Reduce exposure to hyperoxia without a substantive increase in hypoxic episodes or adverse effects

Tracking Information

NCT #
NCT04534972
Collaborators
United States Department of Defense
Investigators
Principal Investigator: Adit Ginde, MD, MPH University of Colorado, Denver