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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

Must not have

Age <18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Supplemental Oxygen Free Days (SOFD)

Secondary study objectives

Oxygen

Discharge Disposition

Duration of Hyperoxemic Event (SpO2>96%)

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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).

0 / 1Eligibility criteria met