On-Demand Oxygen Delivery System Study

NCT ID: NCT02962570

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Oxygen Delivery Patient Monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

On Demand Oxygen Delivery

Intervention Type DEVICE

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

Traditional, Always-On, Oxygen Delivery

Intervention Type DEVICE

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

Oxygen Flow Stopped

Intervention Type DEVICE

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

Interventions

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On Demand Oxygen Delivery

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

Intervention Type DEVICE

Traditional, Always-On, Oxygen Delivery

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

Intervention Type DEVICE

Oxygen Flow Stopped

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Kai Kuck

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai Kuck, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah Department of Anesthesiology

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 14744265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15481269 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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IRB_00094640

Identifier Type: -

Identifier Source: org_study_id

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