On-Demand Oxygen Delivery System Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Patient Monitoring; Oxygen Delivery
• Intervention / Treatment: Device: On Demand Oxygen Delivery; Device: Traditional, Always-On, Oxygen Delivery; Device: Oxygen Flow Stopped

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University Of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Only Arm; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Kai Kuck, Ph.D., University of Utah Department of Anesthesiology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimated): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB_00094640

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data.