Positive Airway Pressure (PAP) System Evaluation in Volunteers
Evaluation of a Novel Positive Airway Pressure System in Volunteers
1 other identifier
interventional
25
0 countries
N/A
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 23, 2025
December 1, 2025
5 months
November 17, 2025
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tidal Volume Accuracy
The mean and standard deviation of the percent difference in tidal volume measurement between our PAP system and the respiratory monitor
During the intervention
Secondary Outcomes (3)
Respiratory Rate
During the intervention
EtCO2
During the intervention
Mask Pressure Control Accuracy
During the intervention
Study Arms (1)
CPAP
EXPERIMENTALAirway pressure support through the investigational device
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
You may not qualify if:
- Have any respiratory or cardiovascular conditions
- i.e., cold, allergies, congestion, pneumonia, lung cancer, COPD, acute respiratory distress syndrome, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Dynasthetics LLCcollaborator
Related Publications (2)
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.
PMID: 30633057BACKGROUNDFogarty 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.
PMID: 31760586BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kai Kuck, PhD
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 24, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 23, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share