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On-Demand Oxygen Delivery System Study

NCT02962570 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Oxygen Delivery
  • Patient Monitoring

Interventions

DEVICE

On Demand Oxygen Delivery

Supplemental oxygen flow is controlled such that it is on only during inhalation.

DEVICE

Traditional, Always-On, Oxygen Delivery

Supplemental oxygen flow is constantly on, irrespective of whether the patient is inhaling or exhaling.

DEVICE

Oxygen Flow Stopped

Supplemental oxygen flow is stopped completely for a brief period to allow undisturbed end-tidal oxygen and CO2 measurements

Sponsors & Collaborators

Principal Investigators

  • Kai Kuck, Ph.D. · University of Utah Department of Anesthesiology

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02962570 on ClinicalTrials.gov