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

Phase 3
Waitlist Available
Led By Adit Ginde, MD, MPH
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights

SAVE-O2 Trial Summary

This trial will test whether a multimodal educational intervention can help to reduce the use of supplemental oxygen in critically injured patients. Additionally, the trial will evaluate the safety and clinical effectiveness of more targeted oxygen therapy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on education around optimal oxygen levels rather than a new medication or procedure, side effects are related to potential risks of not using excess supplemental oxygen which could include low blood oxygen.

SAVE-O2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Supplemental Oxygen Free Days (SOFD)
Secondary outcome measures
Oxygen
Discharge Disposition
Duration of Hyperoxemic Event (SpO2>96%)
+13 more

SAVE-O2 Trial Design

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).

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,757 Previous Clinical Trials
2,160,139 Total Patients Enrolled
10 Trials studying Critical Illness
3,861 Patients Enrolled for Critical Illness
United States Department of DefenseFED
873 Previous Clinical Trials
323,963 Total Patients Enrolled
5 Trials studying Critical Illness
7,887 Patients Enrolled for Critical Illness
Adit Ginde, MD, MPHPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
2,572 Total Patients Enrolled
2 Trials studying Critical Illness
2,572 Patients Enrolled for Critical Illness

Media Library

Multimodal Educational Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04534959 — Phase 3
Critical Illness Research Study Groups: Pre-Implementation, Post-Implementation Targeting Normoxemia in Trauma ICU
Critical Illness Clinical Trial 2023: Multimodal Educational Intervention Highlights & Side Effects. Trial Name: NCT04534959 — Phase 3
Multimodal Educational Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04534959 — Phase 3
~1309 spots leftby Jun 2025
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