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Active, Not Recruiting

NCT Number: NCT02962570

On-Demand Oxygen Delivery System Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Oxygen Delivery Patient Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA class I-III

Exclusion criteria

  • Procedures scheduled for a lime less than 20 minutes
  • Age < 18 years
  • Baseline SpO2 (arterial oxygen saturation as measured by pulse oximetry) < 93% on room air
  • ARDS (Acute respiratory distress syndrome), lung disease, cardiovascular disease
  • ASA class IV or above
  • Pregnant women.

Treatment and study plan

On Demand Oxygen Delivery

Device

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

Traditional, Always-On, Oxygen Delivery

Device

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

Oxygen Flow Stopped

Device

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

Primary outcomes

  1. End-tidal Oxygen

    Time frame: measured every 140 seconds minutes throughout the surgical procedure

    Did the novel system increase end-tidal oxygen?

  2. Oxygen Saturation

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

    Did the novel system increase oxygen saturation?

  3. End-tidal Carbon Dioxide

    Time frame: measured every 140 seconds minutes throughout the surgical procedure

    Was end-tidal carbon dioxide measured more accurately using the novel system?

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Comparison of an On-Demand Oxygen Delivery System to Continuous Flow Supplemental Oxygen in the Operating/Procedure Room

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Nov 11, 2016
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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