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Oxygen (FiO2) Titration per E-alerts for Hyperoxia

N/A
Recruiting
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 28-30 days
Awards & highlights

Study Summary

This trial is comparing two methods of adjusting the oxygen levels for critically ill adults on mechanical ventilation. One group will receive reminders to adjust their oxygen based on their oxygen saturation levels, while the other group will

Who is the study for?
This trial is for adults over 18 years old who are critically ill and require mechanical ventilation. It's not suitable for those who don't meet the age requirement or aren't on mechanical breathing support.Check my eligibility
What is being tested?
The OPTI-Oxygen trial tests a new system that uses electronic alerts to help adjust oxygen levels in patients on ventilators. The goal is to see if this method, compared to standard care, better manages oxygen saturation in critically ill adults.See study design
What are the potential side effects?
Since the intervention involves adjusting existing treatment protocols rather than introducing a new medication, direct side effects from the intervention itself are not anticipated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of 28-30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 28-30 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
Proportion of time during mechanical ventilation spent within target range, SpO2 of 90-94% (conservative) and SpO2 of 93-97% (liberal) with FiO2<=0.4 in respective algorithms.
Secondary outcome measures
Hospital mortality
ICU-Free Days
Length of ICU stay
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Oxygen (FiO2) Titration per E-alertsExperimental Treatment1 Intervention
All eligible mechanically ventilated patients, FiO2 titration and SpO2 goal range will be based on the correlation between SpO2 and arterial oxygen saturation (SaO2). E-alerts will be sent in the intervention arm as reminders for FiO2 titration.
Group II: Oxygen Titration per Standard of CareActive Control1 Intervention
In the control arm, patients will have oxygen titrated per current standard of care (SpO2=88-92%, titrate FiO2 at least every 4 hours). Physician place oxygen titration orders in EMR and respiratory therapists conduct FiO2 titration without electronic alerts.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
504,684 Total Patients Enrolled
2 Trials studying Hyperoxia
5,702 Patients Enrolled for Hyperoxia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,851,188 Total Patients Enrolled

Frequently Asked Questions

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

Are researchers currently enrolling participants for this study?

"According to the details provided on clinicaltrials.gov, this trial is presently in the recruitment phase. The initial posting occurred on January 15th, 2024 and the most recent update was made on January 17th, 2024."

Answered by AI

What is the current number of individuals being admitted into this research investigation?

"Indeed, the information provided on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible participants. It was initially posted on January 15th, 2024 and recently updated on January 17th, 2024. The study aims to enroll a total of 936 individuals at a single designated site."

Answered by AI
~624 spots leftby Aug 2025