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

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Targeted Oxygen Therapy for Critical Illness from Injuries?

Research suggests that avoiding both low and high oxygen levels can reduce complications and death in critically ill patients, including those with trauma. Studies have shown that targeted oxygen levels, which aim to maintain a balanced oxygen level, may improve patient outcomes by preventing harmful effects of too much or too little oxygen. ^{1 2 3 4 5}

Is targeted oxygen therapy safe for humans?

Research suggests that targeted oxygen therapy, which aims to avoid too little or too much oxygen, is generally safe for critically ill patients, including those with severe injuries. Studies have focused on maintaining safe oxygen levels to reduce risks and improve outcomes. ^{1 4 6 7 8}

How does Targeted Oxygen Therapy differ from other treatments for critical illness from injuries?

Targeted Oxygen Therapy is unique because it focuses on maintaining specific oxygen levels in the blood to avoid both low oxygen (hypoxia) and high oxygen (hyperoxia), which can improve outcomes in critically ill patients. This approach contrasts with traditional methods that may not precisely control oxygen levels, potentially leading to complications. ^{1 2 4 6 9}

Research Team

Adit Ginde, MD, MPH

Principal Investigator

University of Colorado, Denver

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A quasiexperimental study of targeted normoxia in critically ill trauma patients. [2023]

2. England pubmed.ncbi.nlm.nih.gov

ICONIC study-conservative versus conventional oxygenation targets in intensive care patients: study protocol for a randomized clinical trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Respiratory oxygen uptake is associated with survival in a cohort of ventilated trauma and burn patients. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The handling oxygenation targets in the intensive care unit (HOT-ICU) trial: Detailed statistical analysis plan. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Intensive care clinicians' opinion of conservative oxygen therapy (SpO₂ 90-92%) for mechanically ventilated patients. [2014]

7. Pakistan pubmed.ncbi.nlm.nih.gov

Pediatric Oxygen Therapy: A Clinical Update. [2018]

8. China pubmed.ncbi.nlm.nih.gov

[Guiding value of brain tissue oxygenation plus intracranial pressure monitoring in severe traumatic brain injury patients]. [2013]

9. Egypt pubmed.ncbi.nlm.nih.gov

Survey of Oxygen Delivery Practices in UK Paediatric Intensive Care Units. [2022]