Targeted Oxygen Therapy for Critical Illness from Injuries

(SAVE-O2 Trial)

Recruiting at 7 trial locations

Overseen By Adit Ginde, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Colorado, Denver

Disqualifiers: Age <18, Prisoners, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if targeted oxygen therapy can aid critically injured patients in recovering more effectively. Researchers are testing a new multimodal educational intervention to ensure the safe and effective use of oxygen for these patients. Participants may include those who have suffered severe injuries and are admitted to a surgical or trauma intensive care unit (ICU) within 24 hours of hospital arrival. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that targeted oxygen therapy is generally safe for very sick patients. One study found that aiming for normal blood oxygen levels can safely reduce the use of extra oxygen without increasing the risk of death or causing low oxygen levels. Another study demonstrated that patients with careful oxygen targets had a lower death rate compared to those with standard targets.

Observational studies suggest that maintaining blood oxygen levels in a moderate range (about 94 to 96%) is linked to better outcomes. Overall, these findings indicate that targeted oxygen therapy is well-tolerated and may even enhance safety for very sick patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores targeted oxygen therapy, which aims to fine-tune oxygen levels for trauma patients in the ICU. Unlike traditional methods that often deliver a standard amount of oxygen, this approach focuses on achieving normoxemia, the optimal balance of oxygen, which could potentially enhance patient recovery and reduce complications. By implementing a multimodal educational intervention alongside this targeted therapy, the trial also aims to improve the consistency and effectiveness of oxygen delivery, paving the way for a more personalized and precise approach in critical care settings.

What evidence suggests that this trial's treatments could be effective for critical illness from injuries?

Research has shown that targeted oxygen therapy, which participants in this trial may receive, can reduce the need for extra oxygen without increasing the risk of death or dangerously low oxygen levels. Studies have found that maintaining normal oxygen levels in critically ill patients is safe and does not lead to worse outcomes. For instance, one study found that keeping oxygen saturation (the amount of oxygen in the blood) between 94% and 96% led to better results than higher levels. Another study observed lower death rates with careful oxygen management. These findings suggest that targeted oxygen therapy might be a safer and more effective way to treat critically injured patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Adit Ginde, MD, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Implementation

Control group of trauma patients admitted to the surgical/trauma ICU during the site's control period

up to 22 months

Post-Implementation

Intervention group with targeted normoxemia intervention in the surgical/trauma ICU

up to 25 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Educational Intervention
• Targeted Oxygen Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Post-Implementation Targeting Normoxemia in Trauma ICU Experimental Treatment 1 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-Implementation Active Control 1 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).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a study of 46 patients with severe traumatic brain injury (TBI), those monitored with both intracranial pressure (ICP) and brain tissue oxygenation (PbtO2) showed a significantly lower mortality rate of 8.7% compared to 21.7% in those monitored with ICP alone.

Patients receiving combined ICP and PbtO2 monitoring also had a better recovery outcome, with 65.2% achieving favorable results on the Glasgow outcome scale, compared to 47.8% in the ICP-only group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Guiding value of brain tissue oxygenation plus intracranial pressure monitoring in severe traumatic brain injury patients]. Wang, QP., Zhang, SM., Gao, H., et al.[2013]

Oxygen therapy is crucial for hospitalized children to prevent or treat tissue hypoxia, but it must be prescribed carefully like any medication to avoid inappropriate use.

The article emphasizes the importance of understanding the indications, administration, monitoring, and potential risks of oxygen therapy to maximize its benefits and minimize toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Oxygen Therapy: A Clinical Update. Haque, A., Rizvi, M., Arif, F.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12169140/

Systematic review of oxygenation and clinical outcomes to ... We conducted a systematic review of oxygen targets and clinical outcomes in trauma and critically ill patients. We searched Ovid MEDLINE, Cochrane Library, ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831952

Targeted Normoxemia and Supplemental Oxygen–Free ... The findings indicate that targeting normoxemia can safely reduce supplemental oxygen use without affecting mortality or time spent in hypoxemia.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2208415

Oxygen-Saturation Targets for Critically Ill Adults Receiving ... Observational studies have reported a U-shaped association between oxygenation and clinical outcomes, with intermediate Spo2 values of approximately 94 to 96% ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12054680/

Oxygen targets in critically ill patients - PubMed Central - NIH In the Oxy-PICU trial, Peters et al.46 compared the role of conservative (SpO2 88–92%) versus liberal (SpO2 > 94%) oxygenation targets on major outcomes ...

5. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-025-05254-5

the case for individualising oxygen therapy in critically ill patients Mortality was reported as 11.6% in the conservative and 20.2% in the conventional oxygenation groups (p = 0.01). The trial received considerable ...