Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers

December 12, 2017 updated by: Joseph Orr, University of Utah
This study will evaluate patient comfort and oxygen delivery efficiency when providing supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen delivery system. The goals of the study are to evaluate different oxygen flow rates and oxygen delivery modes. In addition, the investigators will investigate if the system can detect apnea (cessation of breathing) and removal of the nasal cannula. The investigators will also investigate how well high flow oxygen delivered only during inspiration is tolerated and how much the end-tidal oxygen increases after two minutes of high oxygen flow delivered only during the inhalation phase of the breath.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.

Exclusion Criteria:

  • Volunteers who self report respiratory diseases such as acute respiratory distress syndrome, pneumonia and lung cancer will be excluded. In addition, volunteers who self report respiratory conditions such as nasal or bronchial congestion due to a cold or allergies will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End-tidal Oxygen
Time Frame: Continuously throughout 30 minute volunteer study
Did the novel system increase end-tidal oxygen?
Continuously throughout 30 minute volunteer study
Patient Comfort
Time Frame: Every 2 minutes up to 30 minutes
Did the patients feel it was more comfortable for a given end-tidal oxygen level?
Every 2 minutes up to 30 minutes
End-tidal Carbon Dioxide
Time Frame: Continuously throughout 30 minute volunteer study
Was end-tidal carbon dioxide measured more accurately using the novel system?
Continuously throughout 30 minute volunteer study
Respiratory Rate
Time Frame: Continuously throughout 30 minute volunteer study
Compared respiratory rate against capnometry.
Continuously throughout 30 minute volunteer study
Oxygen Saturation
Time Frame: Continuously throughout 30 minute volunteer study
Did the novel system increase oxygen saturation?
Continuously throughout 30 minute volunteer study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB_00083180

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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