On-Demand Oxygen Delivery System Study

NCT02962570 | Active Not Recruiting

• 1 other identifier: IRB_00094640
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• End-tidal Oxygen

  Did the novel system increase end-tidal oxygen?

  measured every 140 seconds minutes throughout the surgical procedure

• Oxygen Saturation

  Did the novel system increase oxygen saturation?

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

• End-tidal Carbon Dioxide

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

  measured every 140 seconds minutes throughout the surgical procedure

Study Arms (1)

Only Arm

EXPERIMENTAL

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

Device: On Demand Oxygen Delivery; Device: Traditional, Always-On, Oxygen Delivery; Device: Oxygen Flow Stopped

Interventions

On Demand Oxygen Delivery DEVICE

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

Only Arm

Traditional, Always-On, Oxygen Delivery DEVICE

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

Only Arm

Oxygen Flow Stopped DEVICE

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

Only Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class I-III

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (3)

• Bliss PL, McCoy RW, Adams AB. Characteristics of demand oxygen delivery systems: maximum output and setting recommendations. Respir Care. 2004 Feb;49(2):160-5.

  PMID: 14744265 BACKGROUND

• Fuhrman C, Chouaid C, Herigault R, Housset B, Adnot S. Comparison of four demand oxygen delivery systems at rest and during exercise for chronic obstructive pulmonary disease. Respir Med. 2004 Oct;98(10):938-44. doi: 10.1016/j.rmed.2004.03.010.

  PMID: 15481269 BACKGROUND

• Godbold S, Lowe G, Willis R. Healthcare Professionals Accuracy and Consistency in Setting Oxygen Flowmeters for Patients in an Intensive Care Unit. Respir. Care 59(10):OF26, December 2014.

  BACKGROUND

Study Officials

• Kai Kuck, Ph.D.

  University of Utah Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 11, 2016
• Study Start: November 1, 2016
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)