Respiratory FailureNCT06501118
Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
A study testing Education and Epic notification alert in people with Respiratory Failure and Acute Hypoxemic Respiratory Failure, run by University of Colorado, Denver at 1 site in United States.
Trial summary
A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Acute Hypoxemic Respiratory Failure, Acute Hypoxic Respiratory Failure
- What is being tested?
- Education and Epic notification alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 30 Nov 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to ICU and requiring invasive mechanical ventilation
Who cannot join
- Transferred patients from outside the UCHealth system*:
- Patients with pre-existing disease that requires chronic use of positive pressure ventilation delivered through a tracheostomy*:
- Pregnant women:
- Prisoners
- Patients receiving mechanical ventilation for less than twelve hours
Trial locations and contacts
1 site in 1 country.
About this study
A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range.
Read the detailed description
This project will be a multi-hospital, cluster randomized study to implement a targeted oxygen saturation (SpO2) range of 90-96% in adult patients receiving mechanical ventilation (MV) using a multimodal educational intervention strategy. Hospital-level randomization to receive the intervention will occur sequentially for a phased roll-out of multimodal education and real-time informatics tools to enhance adherence of the targeted SpO2 range in eligible mechanically ventilated patients. This phased roll-out is achieved through a stepped wedge approach in a one-way crossover design in which all participating hospital ICUs will ultimately implement the intervention, and the timing of the intervention implementation is randomly ordered. The intervention will occur using 4 clusters that switch from control to intervention at 4 pre-determined time points, 1 for each cluster. For each switch, the design incorporates a 2-week transition period for staff education/implementation at each cluster, during which training will be delivered to each participating hospital to improve implementation. The investigators will provide standardized education and materials to local stakeholders for hospital and ICU-level implementation. During the transition period, the cluster cannot be considered as either receiving the structured usual care intervention (education-based intervention) or the unstructured usual care control (current state, no education-based intervention), and thus patients treated in the hospital during that period will not be enrolled or included in the analysis.
The investigators define a targeted SpO2 range (90-96%), PaO2 (60-100 mmHg) target based on thresholds defined in recent published work that incorporates expert opinions from the field and includes consensus among critical care COGG members that represent UCHealth hospitals throughout the North, South, and Metro regions as well as the site locations at which the intervention is proposed to occur. The oxygen target range will be defined by an oxygen saturation (SpO2) 90-96%, and when arterial blood gases are available, an arterial oxygen pressure (PaO2) 60-100 mmHg. The intervention will start when patients requiring mechanical ventilation arrive to an ICU in a participating hospital and the intervention will continue for any period of invasive mechanical ventilation required during ICU stay. A project goal is to achieve adherence to >95% of eligible patient-hours spent in the target SpO2 range, excluding time on FiO2 30% when above SpO2 96% or time on FiO2 100% when below SpO2 90%. Each hospital site will contribute pre-implementation (control) and post-implementation (intervention) data, with the start of the consensus-based intervention period defined by the randomized timing in the stepped wedge design.
Patients will be ventilated with a standardized UCHealth-wide mechanical ventilation order-set to achieve these SpO2 and PaO2 goals. These order-sets included the ARDSNetwork low- and high-PEEP/FiO2 arms, as well as developed protocols for alternative modes of ventilation, such as APRV which can be used at the provider teams' discretion. Data collection for Phase I began 9/1/2024 and will end 9/15/2025.
Once all hospital clusters have transitioned to the intervention phase, a nested study will commence that involves a patient-level intervention for mechanically ventilated patients experiencing residual occult hypoxemia among participating UCHealth ICUs (Phase II). Data collection for Phase II began 3/25/2026 and will end 7/31/2026. These patients will be identified automatically in the EHR (EPIC) by comparing the SaO2 from an ABG laboratory procedure to contemporaneous SpO2 flowsheet row values and then will be randomized 1:1 to either an active or silent notification delivered in real-time to members of the provider team alerting them to each OH instance, with a 12-hour notification lockout. A unique research study order will be created in EPIC for this nested, Phase II study to facilitate tracking of outcomes for patients randomized to silent and active notification arms in coordination with a health data compass analyst (HDC).
Educational interventions will include:
- Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase.
- EPIC-generated push notification to (1) alert providers in real-time to the presence of OH in their patient with a time-stamp based on SpO2 and SaO2 values compared from vital signs and arterial blood gas oxygen saturation respectively, and (2) inform them of the potential associations of OH with worse outcomes in similar, critically ill patients, and (3) choices for potential changes to management, including an "acknowledge only" option
- Conditions
- Respiratory Failure, Acute Hypoxemic Respiratory Failure, Acute Hypoxic Respiratory Failure, Hypoxemia, Hypoxia, Hypoxic Respiratory Failure
- Being tested
- Education, Epic notification alert
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
- Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase.
Epic notification alertBehavioural
An education-based intervention that focuses on mitigating Occult Hypoxemia in mechanically ventilated patients and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic to as
- alert (notification) the providers of sustained occult hypoxemia
- silent alert
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Other | SP02 target ranges will be 90-96%. Education about the specific oxygen targets will be provided to the clinical teams. Real time feedback on adherence to the Sp02 target range will be provided by virtual respiratory therapists. Receives: Other: Education |
| Educational intervention Epic alert | Other | An education-based intervention that also focuses on mitigating Occult Hypoxemia in mechanically ventilated patients, and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic as
1. alert (notification) the providers of sustained occult hypoxemia or
2. silent alert The investigators are observing physician behavior in response to alerting them that a patient has occult hypoxemia via an Epic alert. Receives: Behavioral: Epic notification alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator Free Days (Phase I,II)
The number of days the patient will be free of mechanical ventilation
Measured: 30 Days
Secondary outcomes (11)
instances of occult hypoxemia (Phase I,II)
arterial oxygen saturation below 88% when the Sp02 is greater than 90% among all patients
Measured: 30 days
ICU free days (Phase I,II)
Number of days patients are not in the ICU
Measured: 90 days
Hospital free days (Phase I, II)
number of days patients are not hospitalized
Measured: 90 DAYS
90 Day in hospital mortality (Phase I, II)
Patients that die in the hospital before day 90
Measured: 90 days
Time to Mortality to day 90 (Phase I,II)
Patients that die within 90 days
Measured: 90 Days
Oxygen status at discharge (Phase I, II)
What if any oxygen the patient is on at discharge
Measured: 90 days
Incidence of needing high level 02 support (Phase I, II)
The number of times that the patients is in need of heated-high flow nasal cannula (HHFNC) / non-invasive positive pressure ventilation (NIPPV)) after extubation
Measured: 90 days
Discharge disposition (Phase I, II)
Place the patient is discharged to
Measured: 90 days
Changes to mechanical ventilation order set (Phase II)
Quantify the number of changes made to the ventilator order set to attempt to deliver more oxygen to the blood. This will capture FIO2, PEEP, Tidal Volume, Inspiratory Pressure changes as a summary numerical unit of measure.
Measured: 4 hours
Medication changes (Phase II)
Addition or dose change of a medication to try and eliminate occult hypoxemia will be quantified numerically. The investigators will include diuretics, inhaled vasodilators, corticosteroids, Intravenous sedatives, and intravenous paralytics in this summary statistic.
Measured: 4 hours
Additional procedures in response to occult hypoxemia (Phase II)
The investigators will quantify the number of additional procedures that may be performed in response to occult hypoxemia. Chest X-ray, Chest CT Scan, arterial blood gas, and placement of arterial catheter procedures will be included in this summary statistic.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Aggarwal, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501118
- Sponsor's protocol ID
- 24-0065
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dylla L, Douin DJ, Anderson EL, Rice JD, Jackson CL, Bebarta VS, Lindsell CJ, Cheng AC, Schauer SG, Ginde AA. 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. Trials. 2021 Nov 8;22(1):784. doi: 10.1186/s13063-021-05688-6.
PubMed 34749762Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays MA, Stollings JL, Buell KG, Brems JH, Qian ET, Seitz KP, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Han JH, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation. N Engl J Med. 2022 Nov 10;387(19):1759-1769. doi: 10.1056/NEJMoa2208415. Epub 2022 Oct 24.
PubMed 36278971Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2021 Dec 23;385(26):2496. doi: 10.1056/NEJMx210003. No abstract available.
PubMed 34936755Douin DJ, Anderson EL, Dylla L, Rice JD, Jackson CL, Wright FL, Bebarta VS, Schauer SG, Ginde AA. Association Between Hyperoxia, Supplemental Oxygen, and Mortality in Critically Injured Patients. Crit Care Explor. 2021 May 14;3(5):e0418. doi: 10.1097/CCE.0000000000000418. eCollection 2021 May.
PubMed 34036272Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
PubMed 16829207Panwar 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 23808511Rachmale 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 22613692Suzuki 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 23683560Aggarwal NR, Brower RG, Hager DN, Thompson BT, Netzer G, Shanholtz C, Lagakos A, Checkley W; National Institutes of Health Acute Respiratory Distress Syndrome Network Investigators. Oxygen Exposure Resulting in Arterial Oxygen Tensions Above the Protocol Goal Was Associated With Worse Clinical Outcomes in Acute Respiratory Distress Syndrome. Crit Care Med. 2018 Apr;46(4):517-524. doi: 10.1097/CCM.0000000000002886.
PubMed 29261565de 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 20878146Hochberg CH, Semler MW, Brower RG. Oxygen Toxicity in Critically Ill Adults. Am J Respir Crit Care Med. 2021 Sep 15;204(6):632-641. doi: 10.1164/rccm.202102-0417CI.
PubMed 34086536Fawzy A, Wu TD, Wang K, Robinson ML, Farha J, Bradke A, Golden SH, Xu Y, Garibaldi BT. Racial and Ethnic Discrepancy in Pulse Oximetry and Delayed Identification of Treatment Eligibility Among Patients With COVID-19. JAMA Intern Med. 2022 Jul 1;182(7):730-738. doi: 10.1001/jamainternmed.2022.1906.
PubMed 35639368Wong AI, Charpignon M, Kim H, Josef C, de Hond AAH, Fojas JJ, Tabaie A, Liu X, Mireles-Cabodevila E, Carvalho L, Kamaleswaran R, Madushani RWMA, Adhikari L, Holder AL, Steyerberg EW, Buchman TG, Lough ME, Celi LA. Analysis of Discrepancies Between Pulse Oximetry and Arterial Oxygen Saturation Measurements by Race and Ethnicity and Association With Organ Dysfunction and Mortality. JAMA Netw Open. 2021 Nov 1;4(11):e2131674. doi: 10.1001/jamanetworkopen.2021.31674.
PubMed 34730820de 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 19077208Damiani 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 25532567
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT06501118
- Acronym / sponsor ID
- 24-0065
- Conditions
- Respiratory Failure, Acute Hypoxemic Respiratory Failure, Acute Hypoxic Respiratory Failure, Hypoxemia, Hypoxia, Hypoxic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Jul 2024 (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.
A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range.
Detailed description
This project will be a multi-hospital, cluster randomized study to implement a targeted oxygen saturation (SpO2) range of 90-96% in adult patients receiving mechanical ventilation (MV) using a multimodal educational intervention strategy. Hospital-level randomization to receive the intervention will occur sequentially for a phased roll-out of multimodal education and real-time informatics tools to enhance adherence of the targeted SpO2 range in eligible mechanically ventilated patients. This phased roll-out is achieved through a stepped wedge approach in a one-way crossover design in which all participating hospital ICUs will ultimately implement the intervention, and the timing of the intervention implementation is randomly ordered. The intervention will occur using 4 clusters that switch from control to intervention at 4 pre-determined time points, 1 for each cluster. For each switch, the design incorporates a 2-week transition period for staff education/implementation at each cluster, during which training will be delivered to each participating hospital to improve implementation. The investigators will provide standardized education and materials to local stakeholders for hospital and ICU-level implementation. During the transition period, the cluster cannot be considered as either receiving the structured usual care intervention (education-based intervention) or the unstructured usual care control (current state, no education-based intervention), and thus patients treated in the hospital during that period will not be enrolled or included in the analysis.
The investigators define a targeted SpO2 range (90-96%), PaO2 (60-100 mmHg) target based on thresholds defined in recent published work that incorporates expert opinions from the field and includes consensus among critical care COGG members that represent UCHealth hospitals throughout the North, South, and Metro regions as well as the site locations at which the intervention is proposed to occur. The oxygen target range will be defined by an oxygen saturation (SpO2) 90-96%, and when arterial blood gases are available, an arterial oxygen pressure (PaO2) 60-100 mmHg. The intervention will start when patients requiring mechanical ventilation arrive to an ICU in a participating hospital and the intervention will continue for any period of invasive mechanical ventilation required during ICU stay. A project goal is to achieve adherence to >95% of eligible patient-hours spent in the target SpO2 range, excluding time on FiO2 30% when above SpO2 96% or time on FiO2 100% when below SpO2 90%. Each hospital site will contribute pre-implementation (control) and post-implementation (intervention) data, with the start of the consensus-based intervention period defined by the randomized timing in the stepped wedge design.
Patients will be ventilated with a standardized UCHealth-wide mechanical ventilation order-set to achieve these SpO2 and PaO2 goals. These order-sets included the ARDSNetwork low- and high-PEEP/FiO2 arms, as well as developed protocols for alternative modes of ventilation, such as APRV which can be used at the provider teams' discretion. Data collection for Phase I began 9/1/2024 and will end 9/15/2025.
Once all hospital clusters have transitioned to the intervention phase, a nested study will commence that involves a patient-level intervention for mechanically ventilated patients experiencing residual occult hypoxemia among participating UCHealth ICUs (Phase II). Data collection for Phase II began 3/25/2026 and will end 7/31/2026. These patients will be identified automatically in the EHR (EPIC) by comparing the SaO2 from an ABG laboratory procedure to contemporaneous SpO2 flowsheet row values and then will be randomized 1:1 to either an active or silent notification delivered in real-time to members of the provider team alerting them to each OH instance, with a 12-hour notification lockout. A unique research study order will be created in EPIC for this nested, Phase II study to facilitate tracking of outcomes for patients randomized to silent and active notification arms in coordination with a health data compass analyst (HDC).
Educational interventions will include:
- Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase.
- EPIC-generated push notification to (1) alert providers in real-time to the presence of OH in their patient with a time-stamp based on SpO2 and SaO2 values compared from vital signs and arterial blood gas oxygen saturation respectively, and (2) inform them of the potential associations of OH with worse outcomes in similar, critically ill patients, and (3) choices for potential changes to management, including an "acknowledge only" option
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Other | Other: EducationSP02 target ranges will be 90-96%. Education about the specific oxygen targets will be provided to the clinical teams. Real time feedback on adherence to the Sp02 target range will be provided by virtual respiratory therapists. |
| Educational intervention Epic alert | Other | Behavioral: Epic notification alertAn education-based intervention that also focuses on mitigating Occult Hypoxemia in mechanically ventilated patients, and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic as 1. alert (notification) the providers of sustained occult hypoxemia or 2. silent alert The investigators are observing physician behavior in response to alerting them that a patient has occult hypoxemia via an Epic alert. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to ICU and requiring invasive mechanical ventilation
Key exclusion criteria (5 listed)
- Transferred patients from outside the UCHealth system*:
- Patients with pre-existing disease that requires chronic use of positive pressure ventilation delivered through a tracheostomy*:
- Pregnant women:
- Prisoners
- Patients receiving mechanical ventilation for less than twelve hours
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 |
|---|---|---|
| Education1) Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase. | Other | Educational intervention |
| Epic notification alertAn education-based intervention that focuses on mitigating Occult Hypoxemia in mechanically ventilated patients and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic to as 1. alert (notification) the providers of sustained occult hypoxemia 2. silent alert | Behavioural | Educational intervention Epic alert |
Primary outcome
Ventilator Free Days (Phase I,II)
Time frame: 30 Days
The number of days the patient will be free of mechanical ventilation
11 secondary outcomes
instances of occult hypoxemia (Phase I,II)
Time frame: 30 days
ICU free days (Phase I,II)
Time frame: 90 days
Hospital free days (Phase I, II)
Time frame: 90 DAYS
90 Day in hospital mortality (Phase I, II)
Time frame: 90 days
Time to Mortality to day 90 (Phase I,II)
Time frame: 90 Days
Oxygen status at discharge (Phase I, II)
Time frame: 90 days
Incidence of needing high level 02 support (Phase I, II)
Time frame: 90 days
Discharge disposition (Phase I, II)
Time frame: 90 days
Changes to mechanical ventilation order set (Phase II)
Time frame: 4 hours
Medication changes (Phase II)
Time frame: 4 hours
Additional procedures in response to occult hypoxemia (Phase II)
Time frame: 4 hours
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 28 Sep 2026.
- Background: PubMed 34749762Dylla L, Douin DJ, Anderson EL, Rice JD, Jackson CL, Bebarta VS, Lindsell CJ, Cheng AC, Schauer SG, Ginde AA. 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. Trials. 2021 Nov 8;22(1):784. doi: 10.1186/s13063-021-05688-6.
- Background: PubMed 36278971Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays MA, Stollings JL, Buell KG, Brems JH, Qian ET, Seitz KP, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Han JH, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation. N Engl J Med. 2022 Nov 10;387(19):1759-1769. doi: 10.1056/NEJMoa2208415. Epub 2022 Oct 24.
- Background: PubMed 34936755Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2021 Dec 23;385(26):2496. doi: 10.1056/NEJMx210003. No abstract available.
- Background: PubMed 34036272Douin DJ, Anderson EL, Dylla L, Rice JD, Jackson CL, Wright FL, Bebarta VS, Schauer SG, Ginde AA. Association Between Hyperoxia, Supplemental Oxygen, and Mortality in Critically Injured Patients. Crit Care Explor. 2021 May 14;3(5):e0418. doi: 10.1097/CCE.0000000000000418. eCollection 2021 May.
- Background: PubMed 16829207Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
- 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 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 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 29261565Aggarwal NR, Brower RG, Hager DN, Thompson BT, Netzer G, Shanholtz C, Lagakos A, Checkley W; National Institutes of Health Acute Respiratory Distress Syndrome Network Investigators. Oxygen Exposure Resulting in Arterial Oxygen Tensions Above the Protocol Goal Was Associated With Worse Clinical Outcomes in Acute Respiratory Distress Syndrome. Crit Care Med. 2018 Apr;46(4):517-524. doi: 10.1097/CCM.0000000000002886.
- 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 34086536Hochberg CH, Semler MW, Brower RG. Oxygen Toxicity in Critically Ill Adults. Am J Respir Crit Care Med. 2021 Sep 15;204(6):632-641. doi: 10.1164/rccm.202102-0417CI.
- Background: PubMed 35639368Fawzy A, Wu TD, Wang K, Robinson ML, Farha J, Bradke A, Golden SH, Xu Y, Garibaldi BT. Racial and Ethnic Discrepancy in Pulse Oximetry and Delayed Identification of Treatment Eligibility Among Patients With COVID-19. JAMA Intern Med. 2022 Jul 1;182(7):730-738. doi: 10.1001/jamainternmed.2022.1906.
- 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.
Neil Aggarwal, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Epic notification alert in people with Respiratory Failure and Acute Hypoxemic Respiratory Failure, run by University of Colorado, Denver at 1 site 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 1 inclusion and 5 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Ventilator Free Days (Phase I,II) (time frame: 30 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 NCT06501118, which also lists 31 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 28 Sep 2026.