← Back to Search

Device

On-Demand Oxygen Therapy for Patient Monitoring

N/A

Waitlist Available

Led By Kai Kuck, Ph.D.

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Procedures scheduled for a lime less than 20 minutes

Age < 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure

Awards & highlights

No Placebo-Only Group

Summary

This trialis investigating if giving oxygen only when patients breathe in is more effective than constant flow. It will measure the difference in oxygen saturation and end-tidal oxygen levels and end-tidal CO2 when oxygen delivery is off during expiration.

Who is the study for?

This trial is for relatively healthy patients undergoing sedation and pain relief during procedures, who are classified as ASA class I-III. It's not suitable for those with oxygen saturation below 93% on room air, severe lung or heart conditions, pregnant women, very high-risk surgery patients (ASA class IV+), short procedures under 20 minutes, or individuals under 18.

What is being tested?

The study tests if an 'on-demand' oxygen delivery system that provides oxygen only when a patient inhales is more effective than traditional continuous-flow systems. The effectiveness will be measured by blood oxygen levels and the accuracy of CO2 monitoring when the flow is stopped during exhalation.

What are the potential side effects?

While specific side effects aren't listed for this type of device trial, potential risks may include discomfort from wearing the device or inaccuracies in oxygen/CO2 level readings which could affect patient safety.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My procedure is scheduled to last less than 20 minutes.

Select...

I am under 18 years old.

Select...

I have a history of severe lung or heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

End-tidal Carbon Dioxide

End-tidal Oxygen

Oxygen Saturation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Only ArmExperimental Treatment3 Interventions

Two minutes: Intervention: Device: On Demand Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped Two minutes intervention: Device: Traditional, Always-On, Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped Repeat until the end of the surgical procedure

0 / 3Eligibility criteria met