Critical IllnessPhase 3SAVE-O2NCT04534959
Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients
A Phase 3 study testing Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg) in people with Critical Illness and Wounds and Injury, run by University of Colorado, Denver at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Critical Illness, Wounds and Injury, Disease Attributes
- What is being tested?
- Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 8 sitesUnited States
- Study dates
- 15 Oct 2020to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acutely injured patients who meet the criteria for entry into the state or national trauma registry
- Admission to surgical/trauma ICU within 24 hours of hospital arrival
Who cannot join
- Age <18 years
- Prisoners
- Known pregnancy
- Transferred patients not admitted through the emergency department
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama-Birmingham Medical Center
Birmingham, Alabama, 35294
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Denver Health
Denver, Colorado, 80204
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Oregon Health and Sciences University
Portland, Oregon, 97239
About this study
Official title: Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2)
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.
Read the detailed description
Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxemia. Although routine, the practice of excessive over-oxygenation may be harmful. An expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (SpO2) range of 90-96%, an arterial oxygen (PaO2) range of 60-100 mmHg (when applicable), and a fraction of inspired oxygen (FiO2) of 21% for mechanically ventilated patients or room air for nonmechanically ventilated patients.
Specific Aim: The purpose of this study 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.
Hypotheses: Clinical efforts to through a multimodal educational intervention will:
- Improve the proportion of time spent within target normoxemia thresholds (oxygen saturation [SpO2] 90-96% and/or arterial oxygen [PaO2] 60-100 mmHg [when applicable]
- Limit use of excessive supplemental oxygen
- Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects
- Being tested
- Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)
- Keywords
- hypoxia, hyperoxia, trauma, burn, critical illness, supplemental oxygen, oxygenation, SpO2, PaO2, FiO2, normoxia, hypoxemia, normoxemia, hyperoxemia
- Medical subject headings
- Critical Illness, Wounds and Injuries, Disease Attributes, Pathologic Processes, Hypoxia, Hyperoxia, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)Other
Post-implementation of targeted normoxemia through oxygen titration for individual patients. Interventions for treatment of hypoxemia will follow usual local practice. Interventions for treatment of hyperoxemia (SpO2 >96% or PaO2 >100 mmHg) will involve down titration of FiO2 (or supplemental oxygen for non-mechanically ventilated patients) within a time frame based on local site preferences-typically in increments of no greater than 0.10 until goal oxygenation in the normoxemia range is achieved (including room air [no supplemental oxygen] for non-mechanically ventilated patients).
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation | No 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). |
| Post-Implementation Targeting Normoxemia in Trauma ICU | Experimental | 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). Receives: Other: Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supplemental Oxygen Free Days (SOFD)
Number of days alive and not on supplemental oxygen during the index hospitalization (0 days [worst outcome] to 28 days [best outcome])
Measured: up to 28 days
Secondary outcomes (16)
Hospital-Free Days to day 90 (HFD90)
Number of days alive and outside the hospital (0 days [worst outcome] to 90 days [best outcome])
Measured: up to 90 days
In-hospital Mortality to day 90
Dichotomous vital status (survived or died) at hospital discharge or day 90, whichever is first
Measured: up to 90 days
Time to Mortality to day 90
Vital status and date of death censored at hospital discharge or day 90, whichever is first
Measured: up to 90 days
Ventilator Free Day (VFD) to day 28
Ventilator Free Days = Days off ventilator (0 VFD [worst outcome] to 28 VFD [best outcome])
Measured: up to 28 days
Time to Room Air
Duration of supplemental oxygen (FiO2 = 0.21 or room air)
Measured: up to 90 days
Glasgow Outcome Score (GOS)
Patient will be assessed at hospital discharge with one of the following five categories: Death, Persistent Vegetative State, Severe Disability, Moderate Disability, Low Disability
Measured: up to 90 days
Discharge Disposition
Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility)
Measured: up to 90 days
Amount of Supplemental Oxygen Administered
Total estimated oxygen volume while in the ICU after hospital arrival
Measured: up to 90 days
Duration of Time on Normoxemia Protocol Target
Defined as SpO2 90-96% or receiving no supplemental oxygen (FiO2 0.21 or room air) while in the ICU
Measured: up to 90 days
Proportion of Participants Receiving High Levels of Supplemental Oxygen
FiO2>0.40 or >4 liters per minute for >2 hours while in the ICU [excludes time in the operating room]
Measured: up to 90 days
Duration of Time receiving High Levels of Supplemental Oxygen
FiO2>0.40 or >4 liters per minute while in the ICU
Measured: up to 90 days
Duration of Time Receiving No Supplemental Oxygen
FiO2 0.21 or room air while in the ICU
Measured: up to 90 days
Incidence of Hypoxemic Event (SpO2<88%)
SpO2 saturation below 88% while in the ICU
Measured: up to 28 days
Duration of Hypoxemic Events (SpO2<88%)
SpO2 saturation below 88% while in the ICU
Measured: up to 90 days
incidence of Hyperoxemic Event (SpO2>96%)
SpO2 saturation above 96% while in the ICU
Measured: up to 90 days
Duration of Hyperoxemic Event (SpO2>96%)
SpO2 saturation above 96% while in the ICU
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start15 Oct 2020
- Primary completion15 Nov 2022
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Adit Ginde, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534959
- Sponsor's protocol ID
- 19-2153
- Acronym
- SAVE-O2
- Status last verified
- Mar 2025
- First submitted
- 25 Aug 2020
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leverve XM. To cope with oxygen: a long and still tumultuous story for life. Crit Care Med. 2008 Feb;36(2):637-8. doi: 10.1097/CCM.0B013E31816296AD. No abstract available.
PubMed 18216624Damiani E, Adrario E, Girardis M, Romano R, Pelaia P, Singer M, Donati A. Arterial hyperoxia and mortality in critically ill patients: a systematic review and meta-analysis. Crit Care. 2014 Dec 23;18(6):711. doi: 10.1186/s13054-014-0711-x.
PubMed 25532567Panwar R, Capellier G, Schmutz N, Davies A, Cooper DJ, Bailey M, Baguley D, Pilcher V, Bellomo R. Current oxygenation practice in ventilated patients-an observational cohort study. Anaesth Intensive Care. 2013 Jul;41(4):505-14. doi: 10.1177/0310057X1304100412.
PubMed 23808511Suzuki S, Eastwood GM, Peck L, Glassford NJ, Bellomo R. Current oxygen management in mechanically ventilated patients: a prospective observational cohort study. J Crit Care. 2013 Oct;28(5):647-54. doi: 10.1016/j.jcrc.2013.03.010. Epub 2013 May 15.
PubMed 23683560Rachmale S, Li G, Wilson G, Malinchoc M, Gajic O. Practice of excessive F(IO(2)) and effect on pulmonary outcomes in mechanically ventilated patients with acute lung injury. Respir Care. 2012 Nov;57(11):1887-93. doi: 10.4187/respcare.01696. Epub 2012 May 15.
PubMed 22613692Parke RL, Eastwood GM, McGuinness SP; George Institute for Global Health; Australian and New Zealand Intensive Care Society Clinical Trials Group. Oxygen therapy in non-intubated adult intensive care patients: a point prevalence study. Crit Care Resusc. 2013 Dec;15(4):287-93.
PubMed 24289510Iscoe S, Beasley R, Fisher JA. Supplementary oxygen for nonhypoxemic patients: O2 much of a good thing? Crit Care. 2011;15(3):305. doi: 10.1186/cc10229. Epub 2011 Jun 30.
PubMed 21722334Panwar R, Young P, Capellier G. Conservative oxygen therapy in mechanically ventilated patients. Crit Care Med. 2014 Sep;42(9):e630-1. doi: 10.1097/CCM.0000000000000439. No abstract available.
PubMed 25126814de Graaff AE, Dongelmans DA, Binnekade JM, de Jonge E. Clinicians' response to hyperoxia in ventilated patients in a Dutch ICU depends on the level of FiO2. Intensive Care Med. 2011 Jan;37(1):46-51. doi: 10.1007/s00134-010-2025-z. Epub 2010 Sep 28.
PubMed 20878146Girardis M, Busani S, Damiani E, Donati A, Rinaldi L, Marudi A, Morelli A, Antonelli M, Singer M. Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1583-1589. doi: 10.1001/jama.2016.11993.
PubMed 27706466de Jonge E, Peelen L, Keijzers PJ, Joore H, de Lange D, van der Voort PH, Bosman RJ, de Waal RA, Wesselink R, de Keizer NF. Association between administered oxygen, arterial partial oxygen pressure and mortality in mechanically ventilated intensive care unit patients. Crit Care. 2008;12(6):R156. doi: 10.1186/cc7150. Epub 2008 Dec 10.
PubMed 19077208Pannu SR. Too Much Oxygen: Hyperoxia and Oxygen Management in Mechanically Ventilated Patients. Semin Respir Crit Care Med. 2016 Feb;37(1):16-22. doi: 10.1055/s-0035-1570359. Epub 2016 Jan 28.
PubMed 26820270Kallet RH, Branson RD. Should Oxygen Therapy Be Tightly Regulated to Minimize Hyperoxia in Critically Ill Patients? Respir Care. 2016 Jun;61(6):801-17. doi: 10.4187/respcare.04933.
PubMed 27235315Hafner S, Beloncle F, Koch A, Radermacher P, Asfar P. Hyperoxia in intensive care, emergency, and peri-operative medicine: Dr. Jekyll or Mr. Hyde? A 2015 update. Ann Intensive Care. 2015 Dec;5(1):42. doi: 10.1186/s13613-015-0084-6. Epub 2015 Nov 19.
PubMed 26585328Helmerhorst HJ, Roos-Blom MJ, van Westerloo DJ, de Jonge E. Association Between Arterial Hyperoxia and Outcome in Subsets of Critical Illness: A Systematic Review, Meta-Analysis, and Meta-Regression of Cohort Studies. Crit Care Med. 2015 Jul;43(7):1508-19. doi: 10.1097/CCM.0000000000000998.
PubMed 25855899
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2)
- ClinicalTrials.gov ID
- NCT04534959
- Acronym / sponsor ID
- SAVE-O2 / 19-2153
- Keywords
- hypoxia, hyperoxia, trauma, burn, critical illness, supplemental oxygen, oxygenation, SpO2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxemia. Although routine, the practice of excessive over-oxygenation may be harmful. An expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (SpO2) range of 90-96%, an arterial oxygen (PaO2) range of 60-100 mmHg (when applicable), and a fraction of inspired oxygen (FiO2) of 21% for mechanically ventilated patients or room air for nonmechanically ventilated patients.
Specific Aim: The purpose of this study 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.
Hypotheses: Clinical efforts to through a multimodal educational intervention will:
- Improve the proportion of time spent within target normoxemia thresholds (oxygen saturation [SpO2] 90-96% and/or arterial oxygen [PaO2] 60-100 mmHg [when applicable]
- Limit use of excessive supplemental oxygen
- Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation | No 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). |
| Post-Implementation Targeting Normoxemia in Trauma ICU | Experimental | Other: Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)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). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acutely injured patients who meet the criteria for entry into the state or national trauma registry
- Admission to surgical/trauma ICU within 24 hours of hospital arrival
Key exclusion criteria (4 listed)
- Age <18 years
- Prisoners
- Known pregnancy
- Transferred patients not admitted through the emergency department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)Post-implementation of targeted normoxemia through oxygen titration for individual patients. Interventions for treatment of hypoxemia will follow usual local practice. Interventions for treatment of hyperoxemia (SpO2 >96% or PaO2 >100 mmHg) will involve down titration of FiO2 (or supplemental oxygen for non-mechanically ventilated patients) within a time frame based on local site preferences-typically in increments of no greater than 0.10 until goal oxygenation in the normoxemia range is achieved (including room air [no supplemental oxygen] for non-mechanically ventilated patients). | Other | Post-Implementation Targeting Normoxemia in Trauma ICU |
Primary outcome
Supplemental Oxygen Free Days (SOFD)
Time frame: up to 28 days
Number of days alive and not on supplemental oxygen during the index hospitalization (0 days [worst outcome] to 28 days [best outcome])
16 secondary outcomes
Hospital-Free Days to day 90 (HFD90)
Time frame: up to 90 days
In-hospital Mortality to day 90
Time frame: up to 90 days
Time to Mortality to day 90
Time frame: up to 90 days
Ventilator Free Day (VFD) to day 28
Time frame: up to 28 days
Time to Room Air
Time frame: up to 90 days
Glasgow Outcome Score (GOS)
Time frame: up to 90 days
Discharge Disposition
Time frame: up to 90 days
Amount of Supplemental Oxygen Administered
Time frame: up to 90 days
Duration of Time on Normoxemia Protocol Target
Time frame: up to 90 days
Proportion of Participants Receiving High Levels of Supplemental Oxygen
Time frame: up to 90 days
Duration of Time receiving High Levels of Supplemental Oxygen
Time frame: up to 90 days
Duration of Time Receiving No Supplemental Oxygen
Time frame: up to 90 days
Incidence of Hypoxemic Event (SpO2<88%)
Time frame: up to 28 days
Duration of Hypoxemic Events (SpO2<88%)
Time frame: up to 90 days
incidence of Hyperoxemic Event (SpO2>96%)
Time frame: up to 90 days
Duration of Hyperoxemic Event (SpO2>96%)
Time frame: up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 18216624Leverve XM. To cope with oxygen: a long and still tumultuous story for life. Crit Care Med. 2008 Feb;36(2):637-8. doi: 10.1097/CCM.0B013E31816296AD. No abstract available.
- Background: PubMed 25532567Damiani E, Adrario E, Girardis M, Romano R, Pelaia P, Singer M, Donati A. Arterial hyperoxia and mortality in critically ill patients: a systematic review and meta-analysis. Crit Care. 2014 Dec 23;18(6):711. doi: 10.1186/s13054-014-0711-x.
- Background: PubMed 23808511Panwar R, Capellier G, Schmutz N, Davies A, Cooper DJ, Bailey M, Baguley D, Pilcher V, Bellomo R. Current oxygenation practice in ventilated patients-an observational cohort study. Anaesth Intensive Care. 2013 Jul;41(4):505-14. doi: 10.1177/0310057X1304100412.
- Background: PubMed 23683560Suzuki S, Eastwood GM, Peck L, Glassford NJ, Bellomo R. Current oxygen management in mechanically ventilated patients: a prospective observational cohort study. J Crit Care. 2013 Oct;28(5):647-54. doi: 10.1016/j.jcrc.2013.03.010. Epub 2013 May 15.
- Background: PubMed 22613692Rachmale S, Li G, Wilson G, Malinchoc M, Gajic O. Practice of excessive F(IO(2)) and effect on pulmonary outcomes in mechanically ventilated patients with acute lung injury. Respir Care. 2012 Nov;57(11):1887-93. doi: 10.4187/respcare.01696. Epub 2012 May 15.
- Background: PubMed 24289510Parke RL, Eastwood GM, McGuinness SP; George Institute for Global Health; Australian and New Zealand Intensive Care Society Clinical Trials Group. Oxygen therapy in non-intubated adult intensive care patients: a point prevalence study. Crit Care Resusc. 2013 Dec;15(4):287-93.
- Background: PubMed 21722334Iscoe S, Beasley R, Fisher JA. Supplementary oxygen for nonhypoxemic patients: O2 much of a good thing? Crit Care. 2011;15(3):305. doi: 10.1186/cc10229. Epub 2011 Jun 30.
- Background: PubMed 25126814Panwar R, Young P, Capellier G. Conservative oxygen therapy in mechanically ventilated patients. Crit Care Med. 2014 Sep;42(9):e630-1. doi: 10.1097/CCM.0000000000000439. No abstract available.
- Background: PubMed 20878146de Graaff AE, Dongelmans DA, Binnekade JM, de Jonge E. Clinicians' response to hyperoxia in ventilated patients in a Dutch ICU depends on the level of FiO2. Intensive Care Med. 2011 Jan;37(1):46-51. doi: 10.1007/s00134-010-2025-z. Epub 2010 Sep 28.
- Background: PubMed 27706466Girardis M, Busani S, Damiani E, Donati A, Rinaldi L, Marudi A, Morelli A, Antonelli M, Singer M. Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1583-1589. doi: 10.1001/jama.2016.11993.
- Background: PubMed 19077208de Jonge E, Peelen L, Keijzers PJ, Joore H, de Lange D, van der Voort PH, Bosman RJ, de Waal RA, Wesselink R, de Keizer NF. Association between administered oxygen, arterial partial oxygen pressure and mortality in mechanically ventilated intensive care unit patients. Crit Care. 2008;12(6):R156. doi: 10.1186/cc7150. Epub 2008 Dec 10.
- Background: PubMed 26820270Pannu SR. Too Much Oxygen: Hyperoxia and Oxygen Management in Mechanically Ventilated Patients. Semin Respir Crit Care Med. 2016 Feb;37(1):16-22. doi: 10.1055/s-0035-1570359. Epub 2016 Jan 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adit Ginde, MD, MPH principal investigator
University of Colorado, Denver
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg) in people with Critical Illness and Wounds and Injury, run by University of Colorado, Denver at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supplemental Oxygen Free Days (SOFD) (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534959, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.