Oxygen DeliveryNCT02886312
Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers
An observational study of Oxygen Delivery and Patient Monitoring, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxygen Delivery, Patient Monitoring, Patient Comfort
- What is being tested?
- Supplemental Oxygen Delivery System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.
Who may be able to join
- Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Oxygen Delivery, Patient Monitoring, Patient Comfort
- Being tested
- Supplemental Oxygen Delivery System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental Oxygen Delivery SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
End-tidal Oxygen
Did the novel system increase end-tidal oxygen?
Measured: Continuously throughout 30 minute volunteer study
Patient Comfort
Did the patients feel it was more comfortable for a given end-tidal oxygen level?
Measured: Every 2 minutes up to 30 minutes
End-tidal Carbon Dioxide
Was end-tidal carbon dioxide measured more accurately using the novel system?
Measured: Continuously throughout 30 minute volunteer study
Respiratory Rate
Compared respiratory rate against capnometry.
Measured: Continuously throughout 30 minute volunteer study
Oxygen Saturation
Did the novel system increase oxygen saturation?
Measured: Continuously throughout 30 minute volunteer study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oxygen DeliveryStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886312
- Sponsor's protocol ID
- IRB_00083180
- Status last verified
- Dec 2017
- First submitted
- 19 Aug 2016
- Last updated
- 30 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.
PubMed 19294365Sasaki H, Yamakage M, Iwasaki S, Mizuuchi M, Namiki A. Design of oxygen delivery systems influences both effectiveness and comfort in adult volunteers. Can J Anaesth. 2003 Dec;50(10):1052-5. doi: 10.1007/BF03018373.
PubMed 14656787Burk KM, Sakata DJ, Kuck K, Orr JA. Comparing Nasal End-Tidal Carbon Dioxide Measurement Variation and Agreement While Delivering Pulsed and Continuous Flow Oxygen in Volunteers and Patients. Anesth Analg. 2020 Mar;130(3):715-724. doi: 10.1213/ANE.0000000000004004.
PubMed 30633057
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers
- ClinicalTrials.gov ID
- NCT02886312
- Acronym / sponsor ID
- IRB_00083180
- Conditions
- Oxygen Delivery, Patient Monitoring, Patient Comfort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.
Key inclusion criteria (1 listed)
- Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental Oxygen Delivery System | Device | – |
Primary outcome
End-tidal Oxygen
Time frame: Continuously throughout 30 minute volunteer study
Did the novel system increase end-tidal oxygen?
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?
End-tidal Carbon Dioxide
Time frame: Continuously throughout 30 minute volunteer study
Was end-tidal carbon dioxide measured more accurately using the novel system?
Respiratory Rate
Time frame: Continuously throughout 30 minute volunteer study
Compared respiratory rate against capnometry.
Oxygen Saturation
Time frame: Continuously throughout 30 minute volunteer study
Did the novel system increase oxygen saturation?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Background: PubMed 19294365Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.
- Background: PubMed 14656787Sasaki H, Yamakage M, Iwasaki S, Mizuuchi M, Namiki A. Design of oxygen delivery systems influences both effectiveness and comfort in adult volunteers. Can J Anaesth. 2003 Dec;50(10):1052-5. doi: 10.1007/BF03018373.
- Derived from this study: PubMed 30633057Burk KM, Sakata DJ, Kuck K, Orr JA. Comparing Nasal End-Tidal Carbon Dioxide Measurement Variation and Agreement While Delivering Pulsed and Continuous Flow Oxygen in Volunteers and Patients. Anesth Analg. 2020 Mar;130(3):715-724. doi: 10.1213/ANE.0000000000004004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Delivery and Patient Monitoring, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-tidal Oxygen (time frame: Continuously throughout 30 minute volunteer study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886312, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.