← Back to Search

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 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

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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,137,583 Total Patients Enrolled

9 Trials studying Critical Illness

3,561 Patients Enrolled for Critical Illness

United States Department of DefenseFED

861 Previous Clinical Trials

221,194 Total Patients Enrolled

4 Trials studying Critical Illness

7,587 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA acknowledged Targeting Normoxia as an acceptable medical treatment?

"Targeting Normoxia (SpO2 90-96%; PaO2 60-100 mmHg) is considered safe, as it has reached Phase 3 in clinical trials. This means that there is not only data supporting its efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

Is this clinical trial occurring in multiple hospitals throughout Canada?

"The University of Texas Health Science Center at Houston, Denver Health, Oregon Health and Sciences University are a few of the 8 total sites where this clinical trial is taking place."

Answered by AI

Are there any current openings for this experimental treatment program?

"Yes, the information on clinicaltrials.gov points out that this trial is presently searching for candidates. The study was initially posted on 10/15/2020 and was last updated on 8/2/2022. The trial is searching for 6000 participants across 8 locations."

Answered by AI

Is this a youth-friendly clinical trial?

"This clinical trial is seeking participants that fall between 18 and 120 years of age."

Answered by AI

Are there specific entry requirements for this test program?

"Currently, this clinical trial is looking for 6000 individuals that meet the age criteria of being between 18 and 120 years old. Most importantly, applicants should meet the following specific medical requirements: They must have been recently injured and fit the qualifications to be entered into a state or national trauma registry as well as being admitted to a surgical/trauma ICU within 24 hours of hospital arrival."

Answered by AI

How many individuals are taking part in this research project?

"Yes, this trial is still looking for participants. According to the listing on clinicaltrials.gov, which was last updated on 8/2/2022, the study began recruitment on 10/15/2020. They are hoping to enroll 6000 individuals from 8 locations."

Answered by AI

Recent research and studies

Anaesthesia and Intensive CareJournal

Current Oxygenation Practice in Ventilated Patients—an Observational Cohort Study

Panwar, R., G. Capellier, N. Schmutz, A. Davies, D. J. Cooper, M. Bailey, D. Baguley, D. V. Pilcher, and R. Bellomo. 2013. “Current Oxygenation Practice in Ventilated Patients—an Observational Cohort Study”. Anaesthesia and Intensive Care. SAGE Publications. doi:10.1177/0310057x1304100412.

Seminars in Respiratory and Critical Care MedicineJournal

Too Much Oxygen: Hyperoxia and Oxygen Management in Mechanically Ventilated Patients

Pannu, Sonal. 2016. “Too Much Oxygen: Hyperoxia and Oxygen Management in Mechanically Ventilated Patients”. Seminars in Respiratory and Critical Care Medicine. Georg Thieme Verlag KG. doi:10.1055/s-0035-1570359.

Annals of Intensive CareJournal

Hyperoxia in Intensive Care, Emergency, and Peri-operative Medicine: Dr. Jekyll or Mr. Hyde? A 2015 Update

Hafner, Sebastian, François Beloncle, Andreas Koch, Peter Radermacher, and Pierre Asfar. 2015. “Hyperoxia in Intensive Care, Emergency, and Peri-operative Medicine: Dr. Jekyll or Mr. Hyde? A 2015 Update”. Annals of Intensive Care. Springer Science and Business Media LLC. doi:10.1186/s13613-015-0084-6.

Military MedicineJournal