Mechanical VentilationTOOLsNCT04481581
Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts
A study testing Electronic Alerts in people with Mechanical Ventilation, run by Ohio State University at 1 site in United States.
Trial summary
Fractional oxygen during mechanical ventilation, is a life sustaining therapy in the intensive care unit , used for about a million patients annually. Oxygen therapy needs to be tightly balanced as both hypoxia and hyperoxia are harmful. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Electronic Alerts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 1 Oct 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill subjects who require mechanical ventilation for at least 24 hours.
Who cannot join
- Subjects without research authorization,
- Pregnancy,
- Pneumothorax,
- Carbon monoxide poisoning,
- Hyperbaric oxygen therapy
- Acute ST elevation Myocardial Infarction
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Titration of Inspired Oxygen During Mechanical Ventilation Using a Bedside Decision Support Tool
Fractional oxygen during mechanical ventilation, is a life sustaining therapy in the intensive care unit , used for about a million patients annually. Oxygen therapy needs to be tightly balanced as both hypoxia and hyperoxia are harmful. Establishing precision in oxygenation has significant implications for improving patient outcomes, resource utilization and reducing iatrogenic harm to a vulnerable population. The investigators propose an approach using a oxygen titration protocol consisting of electronic health records based alerts to guide oxygen adjustment.
Read the detailed description
The investigators will conduct a prospective randomized, clinical trial in the Medical Intensive Care Unit at Ohio State University Medical Center. In the intervention arm, respiratory therapists' will conduct oxygen titration with the help of a novel, high fidelity, electronic health records based, protocol consisting of electronic alerts and decision support tool. Oxygen titration in the control arm will be done without alerts and will be per "current standard of care".
Participants for this study will be identified and recruited from patients admitted to the Ohio State University, Wexner Medical Center and James Cancer Hospital, Medical Intensive Care Unit.
- Conditions
- Mechanical Ventilation
- Being tested
- Electronic Alerts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic AlertsOther
When FiO2 remains =>0.4 and SpO2 =>94% for more than 45 minutes, an electronic health record based alert will be sent to respiratory therapists to titrate oxygen per decision support tool.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm- Oxygen titration with electronic alerts | Experimental | Oxygen titration will be done based on electronic alerts and decisions support tool by Respiratory Therapists, if FiO2=> 0.4 and SpO2 =>94% for more than 45 minutes Receives: Other: Electronic Alerts |
| Control Arm- Oxygen titration by one time physician orders | No intervention | Oxygen titration will be done ventilator management guidelines for the medical intensive care unit. Titration is done by one-time orders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Hyperoxemia
The degree of excess exposure will be recorded as percent FiO2 >0.4 when saturation continued to remain above 94%. Primary outcome will be determined by the proportion of time the patient will be "exposed to excessive supplied oxygen" divided by the total time under mechanical ventilation.
Measured: Duration of Mechanical Ventilation, an average of 10-14 days
Secondary outcomes (3)
Ventilator Free days
The number of days between successful weaning from mechanical ventilation and day 28 after study enrollment.
Measured: 28 days
ICU length of stay
Duration of stay in the intensive care unit after patient enrollment
Measured: days of ICU stay within hospitalization, average of 20-25 days
Duration of stay in the hospital after patient enrollment
Duration of stay in the hospital after patient enrollment
Measured: Current Hospital Stay, upto 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start5 Jan 2021
- Primary completion1 Feb 2024
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a parallel design, unblinded, randomized (1:1) trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Sonal Pannu, Ohio State University
- Investigators
- Sonal R Pannu, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481581
- Sponsor's protocol ID
- 2014H0236
- Other IDs
- 5KL2TR002734-03
- Acronym
- TOOLs
- Status last verified
- Apr 2025
- First submitted
- 21 Jun 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pannu SR, Haddad T, Exline M, Christman JW, Horowitz JC, Peters J, Brock G, Diaz P, Crouser ED. Rationale and design of a randomized controlled clinical trial; Titration of Oxygen Levels (TOOL) during mechanical ventilation. Contemp Clin Trials. 2022 Aug;119:106811. doi: 10.1016/j.cct.2022.106811. Epub 2022 May 31.
PubMed 35660485
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titration of Inspired Oxygen During Mechanical Ventilation Using a Bedside Decision Support Tool
- ClinicalTrials.gov ID
- NCT04481581
- Acronym / sponsor ID
- TOOLs / 2014H0236
- Conditions
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 22 Jul 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.
Fractional oxygen during mechanical ventilation, is a life sustaining therapy in the intensive care unit , used for about a million patients annually. Oxygen therapy needs to be tightly balanced as both hypoxia and hyperoxia are harmful. Establishing precision in oxygenation has significant implications for improving patient outcomes, resource utilization and reducing iatrogenic harm to a vulnerable population. The investigators propose an approach using a oxygen titration protocol consisting of electronic health records based alerts to guide oxygen adjustment.
Detailed description
The investigators will conduct a prospective randomized, clinical trial in the Medical Intensive Care Unit at Ohio State University Medical Center. In the intervention arm, respiratory therapists' will conduct oxygen titration with the help of a novel, high fidelity, electronic health records based, protocol consisting of electronic alerts and decision support tool. Oxygen titration in the control arm will be done without alerts and will be per "current standard of care".
Participants for this study will be identified and recruited from patients admitted to the Ohio State University, Wexner Medical Center and James Cancer Hospital, Medical Intensive Care Unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a parallel design, unblinded, randomized (1:1) trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm- Oxygen titration with electronic alerts | Experimental | Other: Electronic AlertsOxygen titration will be done based on electronic alerts and decisions support tool by Respiratory Therapists, if FiO2=> 0.4 and SpO2 =>94% for more than 45 minutes |
| Control Arm- Oxygen titration by one time physician orders | No intervention | –Oxygen titration will be done ventilator management guidelines for the medical intensive care unit. Titration is done by one-time orders. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critically ill subjects who require mechanical ventilation for at least 24 hours.
Key exclusion criteria (6 listed)
- Subjects without research authorization,
- Pregnancy,
- Pneumothorax,
- Carbon monoxide poisoning,
- Hyperbaric oxygen therapy
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 |
|---|---|---|
| Electronic AlertsWhen FiO2 remains =>0.4 and SpO2 =>94% for more than 45 minutes, an electronic health record based alert will be sent to respiratory therapists to titrate oxygen per decision support tool. | Other | Intervention arm- Oxygen titration with electronic alerts |
Primary outcome
Duration of Hyperoxemia
Time frame: Duration of Mechanical Ventilation, an average of 10-14 days
The degree of excess exposure will be recorded as percent FiO2 >0.4 when saturation continued to remain above 94%. Primary outcome will be determined by the proportion of time the patient will be "exposed to excessive supplied oxygen" divided by the total time under mechanical ventilation.
3 secondary outcomes
Ventilator Free days
Time frame: 28 days
ICU length of stay
Time frame: days of ICU stay within hospitalization, average of 20-25 days
Duration of stay in the hospital after patient enrollment
Time frame: Current Hospital Stay, upto 30 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 4 Apr 2025.
- Derived from this study: PubMed 35660485Pannu SR, Haddad T, Exline M, Christman JW, Horowitz JC, Peters J, Brock G, Diaz P, Crouser ED. Rationale and design of a randomized controlled clinical trial; Titration of Oxygen Levels (TOOL) during mechanical ventilation. Contemp Clin Trials. 2022 Aug;119:106811. doi: 10.1016/j.cct.2022.106811. Epub 2022 May 31.
- 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.
Sonal R Pannu, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Alerts in people with Mechanical Ventilation, run by Ohio State University 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 6 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 4 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 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?
Duration of Hyperoxemia (time frame: Duration of Mechanical Ventilation, an average of 10-14 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 NCT04481581, which also lists 1 linked publication.
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 4 Apr 2025.