Obstruction AirwayNCT07246538
Positive Airway Pressure (PAP) System Evaluation in Volunteers
A study testing CPAP in people with Obstruction Airway, run by University of Utah at 1 site in United States.
Trial summary
This study will test the control and measurements of a new system for airway support in healthy volunteers. The goals of the study are to evaluate how accurately the system can stabilize airway pressure to a desired level, evaluate the accuracy of the system's reported volume of each breath (tidal volume), evaluate… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstruction Airway
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 4 Mar 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Healthy volunteers
Who cannot join
- Have any respiratory or cardiovascular conditions
- i.e., cold, allergies, congestion, pneumonia, lung cancer, COPD, acute respiratory distress syndrome, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Pain Management Center
Salt Lake City, Utah, 84108
About this study
Official title: Evaluation of a Novel Positive Airway Pressure System in Volunteers
This study will test the control and measurements of a new system for airway support in healthy volunteers. The goals of the study are to evaluate how accurately the system can stabilize airway pressure to a desired level, evaluate the accuracy of the system's reported volume of each breath (tidal volume), evaluate the accuracy of the system's reported respiratory rate, evaluate the accuracy of exhaled carbon dioxide monitoring with a standard carbon dioxide monitor when the novel PAP system is used, and evaluate general comfort of the volunteers while using the system.
Read the detailed description
Sedation procedures involve administering drugs to patients that reduce awareness and pain without complete loss of consciousness. A common side effect of these drugs is partial or complete obstruction of the airway by the airway tissue, inhibiting the flow of oxygen to the lungs. Research has shown that this risk can be effectively reduced by administering PAP therapy during sedation, which involves directing air flow into a tight-fitting mask over the patient's nostrils and/or mouth. However, non-invasive ventilators used for administering PAP therapy are expensive and large, and often not available in areas of the hospital where sedation procedures take place.
The investigators have developed a small and low-cost novel PAP system for use in sedation procedures that controls airway pressure to desired levels (a feature that is generally only available in larger and higher-cost devices), provides estimates for tidal volumes (generally only available with a non-invasive ventilator), provides respiratory rate estimates, and allows for more accurate monitoring of exhaled carbon dioxide with a standard carbon dioxide monitor using a novel approach that to the investigator's knowledge has not been published. The goal of investigator's study is to demonstrate the accuracy of these features in human subjects. The system is much smaller and less expensive than a non-invasive ventilator, provides enhanced respiratory monitoring, and has the potential to be a practical alternative that would make PAP therapy during sedation much more feasible.
The investigator's evaluation will primarily include evaluating the investigator's system's performance against an FDA cleared commercial respiratory monitor to verify accuracy. The investigators anticipate that the investigator's system will automatically adjust oxygen flow to maintain a desired airway pressure even in the presence of variables such as mask leak and patient inhalation flow. The investigators also anticipate that the investigator's system will provide tidal volume estimates within 15% of the respiratory monitor reference measurement, as well as respiratory rate estimates that closely match the respiratory monitor. The investigator's system employs a method that detects when the patient exhales and removes mask pressure during exhalation, and the investigators anticipate that this will result in improved comfort for the patient, as well as improved carbon dioxide monitoring accuracy, since removing flow during exhalation reduces dilution of the expired gas sample that is used for measuring exhaled carbon dioxide levels.
- Conditions
- Obstruction Airway
- Being tested
- CPAP
- Keywords
- Device feasibility
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Airway pressure support through the investigational device
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Enrolled healthy volunteers to examine airway pressure support through the investigational device. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Volume Accuracy
The mean and standard deviation of the percent difference in tidal volume measurement between our PAP system and the respiratory monitor
Measured: During the intervention, up to 20 minutes
Secondary outcomes (3)
Respiratory Rate
The average respiratory rate reported by the respiratory monitor and rate reported by the PAP system for each volunteer will be compared. The average difference for each volunteer will be calculated, and a 95% confidence interval will be constructed, with the ideal mean difference being zero with low variance.
Measured: During the intervention, up to 20 minutes
EtCO2
End-tidal carbon dioxide measurements at 10 cmH2O of mask pressure will be compared between when the system turned off flow during exhalation and when delivering flow throughout the entire breath. We anticipate that end-tidal CO2 levels will read lower when flow is delivered continuously during exhalation because of dilution of the expired gas, and this will be demonstrated by calculating the average difference in end-tidal CO2 between these two approaches.
Measured: During the intervention, up to 20 minutes
Mask Pressure Control Accuracy
The measured pressure in the mask compared to the set pressure in the 50 milliseconds immediately preceding inhalation will be assessed for evaluating pressure control. Average error will be calculated and a 95% confidence interval will be constructed. We anticipate the error to be less than 1 cmH2O.
Measured: During the intervention, up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start10 Feb 2026
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstruction AirwayStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Dynasthetics LLC
- Responsible party
- Sponsor
- Investigators
- Kai Kuck, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246538
- Sponsor's protocol ID
- IRB_00190165
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Burk 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 30633057Fogarty M, Orr JA, Sakata D, Brewer L, Johnson K, Fang JC, Kuck K. A comparison of ventilation with a non-invasive ventilator versus standard O2 with a nasal cannula for colonoscopy with moderate sedation using propofol. J Clin Monit Comput. 2020 Dec;34(6):1215-1221. doi: 10.1007/s10877-019-00426-5. Epub 2019 Nov 23.
PubMed 31760586
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Positive Airway Pressure System in Volunteers
- ClinicalTrials.gov ID
- NCT07246538
- Acronym / sponsor ID
- IRB_00190165
- Conditions
- Obstruction Airway
- Keywords
- Device feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Dynasthetics LLC
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Posted 5 Nov 2026
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 test the control and measurements of a new system for airway support in healthy volunteers. The goals of the study are to evaluate how accurately the system can stabilize airway pressure to a desired level, evaluate the accuracy of the system's reported volume of each breath (tidal volume), evaluate the accuracy of the system's reported respiratory rate, evaluate the accuracy of exhaled carbon dioxide monitoring with a standard carbon dioxide monitor when the novel PAP system is used, and evaluate general comfort of the volunteers while using the system.
Detailed description
Sedation procedures involve administering drugs to patients that reduce awareness and pain without complete loss of consciousness. A common side effect of these drugs is partial or complete obstruction of the airway by the airway tissue, inhibiting the flow of oxygen to the lungs. Research has shown that this risk can be effectively reduced by administering PAP therapy during sedation, which involves directing air flow into a tight-fitting mask over the patient's nostrils and/or mouth. However, non-invasive ventilators used for administering PAP therapy are expensive and large, and often not available in areas of the hospital where sedation procedures take place.
The investigators have developed a small and low-cost novel PAP system for use in sedation procedures that controls airway pressure to desired levels (a feature that is generally only available in larger and higher-cost devices), provides estimates for tidal volumes (generally only available with a non-invasive ventilator), provides respiratory rate estimates, and allows for more accurate monitoring of exhaled carbon dioxide with a standard carbon dioxide monitor using a novel approach that to the investigator's knowledge has not been published. The goal of investigator's study is to demonstrate the accuracy of these features in human subjects. The system is much smaller and less expensive than a non-invasive ventilator, provides enhanced respiratory monitoring, and has the potential to be a practical alternative that would make PAP therapy during sedation much more feasible.
The investigator's evaluation will primarily include evaluating the investigator's system's performance against an FDA cleared commercial respiratory monitor to verify accuracy. The investigators anticipate that the investigator's system will automatically adjust oxygen flow to maintain a desired airway pressure even in the presence of variables such as mask leak and patient inhalation flow. The investigators also anticipate that the investigator's system will provide tidal volume estimates within 15% of the respiratory monitor reference measurement, as well as respiratory rate estimates that closely match the respiratory monitor. The investigator's system employs a method that detects when the patient exhales and removes mask pressure during exhalation, and the investigators anticipate that this will result in improved comfort for the patient, as well as improved carbon dioxide monitoring accuracy, since removing flow during exhalation reduces dilution of the expired gas sample that is used for measuring exhaled carbon dioxide levels.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: CPAPEnrolled healthy volunteers to examine airway pressure support through the investigational device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (2 listed)
- Have any respiratory or cardiovascular conditions
- i.e., cold, allergies, congestion, pneumonia, lung cancer, COPD, acute respiratory distress syndrome, etc.
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 |
|---|---|---|
| CPAPAirway pressure support through the investigational device | Device | CPAP |
Primary outcome
Tidal Volume Accuracy
Time frame: During the intervention, up to 20 minutes
The mean and standard deviation of the percent difference in tidal volume measurement between our PAP system and the respiratory monitor
3 secondary outcomes
Respiratory Rate
Time frame: During the intervention, up to 20 minutes
EtCO2
Time frame: During the intervention, up to 20 minutes
Mask Pressure Control Accuracy
Time frame: During the intervention, up to 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Background: PubMed 31760586Fogarty M, Orr JA, Sakata D, Brewer L, Johnson K, Fang JC, Kuck K. A comparison of ventilation with a non-invasive ventilator versus standard O2 with a nasal cannula for colonoscopy with moderate sedation using propofol. J Clin Monit Comput. 2020 Dec;34(6):1215-1221. doi: 10.1007/s10877-019-00426-5. Epub 2019 Nov 23.
- Individual participant dataSharing planned: No
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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.
Kai Kuck, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Obstruction Airway, 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 2 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 5 Nov 2026. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tidal Volume Accuracy (time frame: During the intervention, up to 20 minutes). 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 NCT07246538, which also lists 2 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 5 Nov 2026.