NCT03789396

Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 572 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 109 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to conduct an observational pre/post study to evaluate the clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in critically ill trauma patients.

Detailed description

Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance of hypoxia is vital, the current clinical practice of excessive oxygenation settings is common, and unnecessary, and may even be harmful. An expert panel convened to define optimal oxygenation targets in critically ill trauma patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of 90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial implementation of this consensus will occur for the care of trauma patients. Specific Aim: This is an observational pre/post study to evaluate the impact of targeted normoxia implementation in optimizing oxygen delivery and oxygenation in critically ill trauma patients. Hypotheses: That the clinical efforts to improve adherence to oxygen guidelines will: 1. improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by 2. reducing utilization of unnecessary supplementation oxygen 3. without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.

Conditions

• Trauma
• Critical Illness
• Oxygen Toxicity

Interventions

Type	Name	Description
OTHER	Targeted Normoxia (oxygen saturation 90-96%)	The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation
OTHER	Usual Care Oxygenation	The control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-09-19
• Completion: 2022-10-01
• First posted: 2018-12-28
• Last updated: 2024-02-15
• Results posted: 2024-02-15

Locations

1 site across 1 country: United States