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Positive Airway Pressure (PAP) System Evaluation in Volunteers

ConditionObstruction Airway
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers

Disqualifiers

Have any respiratory or cardiovascular conditions

i.e., cold, allergies, congestion, pneumonia, lung cancer, COPD, acute respiratory distress syndrome, etc.

Trial design

Design model

Single group

Treatments tested in this trial

  • CPAP

    Device

    Airway pressure support through the investigational device.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: CPAPExperimental treatment 1 intervention

Trial outcomes

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

Time frame
During the intervention

Secondary outcomes

1

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.

Time frame
During the intervention
2

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.

Time frame
During the intervention
3

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.

Time frame
During the intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Dynasthetics LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: