On-Demand Oxygen Therapy for Patient Monitoring

Recruiting in Palo Alto (17 mi)

Overseen byKai Kuck, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Utah

No Placebo Group

Trial Summary

What is the purpose of this trial?The main goal of this study is to determine if supplemental oxygen given only when the patient is inspiring (demand delivery) is more effective than constant-flow oxygen given during all phases of the breath regardless if the patient is breathing it in. A previous study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given in demand (inhalation only) mode. A secondary goal is to determine in patients, whether turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon Dioxide) monitoring. This was found to be the case in the previous volunteer study. The investigators want to determine if these improvements are also observable in relatively healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand mode will be determined by measuring the resulting difference in oxygen saturation and end-tidal oxygen levels. The investigators will alternate between traditional oxygen delivery (continuous flow) and demand delivery (flow only during inhalation) for two minutes in each mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal CO2 measurement will be compared with those during the brief time when O2 flow is stopped.

Eligibility Criteria

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.

Inclusion Criteria

ASA class I-III

Exclusion Criteria

I have a history of severe lung or heart problems.

Pregnant women

My procedure is scheduled to last less than 20 minutes.

+3 more

Participant Groups

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.

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