Targeted Oxygen Therapy for Critical Illness from Injuries
(SAVE-O2 Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byAdit Ginde, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

Eligibility Criteria

This trial is for adults who've been critically injured, are listed in the state or national trauma registry, and admitted to a surgical/trauma ICU within 24 hours of arriving at the hospital. It's not for those under 18, prisoners, pregnant individuals, or patients transferred from other departments.

Inclusion Criteria

Acutely injured patients who meet the criteria for entry into the state or national trauma registry

I was admitted to the ICU for surgery or trauma within 24 hours of arriving at the hospital.

Exclusion Criteria

Transferred patients not admitted through the emergency department

I am under 18 years old.

You are currently pregnant.

+1 more

Participant Groups

The study tests if educating healthcare providers on oxygen use can lead to more precise oxygen therapy (keeping blood oxygen levels within specific limits) and improve outcomes for critically injured patients.

2Treatment groups

Experimental Treatment

Active Control

Group I: Post-Implementation Targeting Normoxemia in Trauma ICUExperimental Treatment1 Intervention

The intervention (post-implementation) group will be patients admitted to the surgical/trauma ICU during the targeted normoxemia intervention period of the stepped-wedge implementation process (up to 25 months).

Group II: Pre-ImplementationActive Control1 Intervention

The control (pre-implementation) group will be trauma patients admitted to the surgical/trauma ICU during the site's control period of the stepped-wedge implementation process (up to 22 months).