Positive Airway Pressure (PAP) System Evaluation in Volunteers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstruction Airway
• Intervention / Treatment: Device: CPAP

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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kai Kuck, PhD; Phone Number: (801) 581-6393; Email: kai.kuck@hsc.utah.edu
• Study Contact Backup: Name: Trey Blackwell, MS; Phone Number: (801) 395-4038; Email: Trey.Blackwell@utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Have any respiratory or cardiovascular conditions
• i.e., cold, allergies, congestion, pneumonia, lung cancer, COPD, acute respiratory distress syndrome, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPAP; Airway pressure support through the investigational device	Device: CPAP; Airway pressure support through the investigational device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the intervention
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.	During the intervention
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 differences at each set pressure will be calculated. We anticipate these numbers to be less than 1 cmH2O.	During the intervention

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Dynasthetics LLC
• Investigators: Principal Investigator: Kai Kuck, PhD, University of Utah

Publications and helpful links

General 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.
• Fogarty 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Estimated): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Device feasibility
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: IRB_00190165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes