Investigation of a Novel Oropharyngeal Airway: The ManMaxAirway
Airway Obstruction, Respiratory Complication
About this trial
This is an interventional treatment trial for Airway Obstruction
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers over the age of 18.
Exclusion Criteria:
- For Tolerability arm: History of Gastroesophageal Reflux Disease, dental implants or dental prostheses
- For the MRI arm, the following were further exclusion criteria as dictated by institutional MRI safety protocols: claustrophobia, cerebral aneurysm clip, nerve stimulation device, cochlear/middle ear implant, transdermal patches, known metal in body (to include IUD), intraventricular shunt, implanted pumps or stents, pregnant, metal implants, cardiac pacemaker, Swan Ganz catheter, metal worker occupation, history of eye injury with metal.
Sites / Locations
- University of Vermont College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Active Comparator
MRI Comparison
Tolerability Comparison
Forced Oscillation
MRI images will be obtained of the airways of healthy volunteers both with the ManMaxAirway oropharyngeal airway adjunct and with no airway adjunct in place in order to observe any changes to the airway anatomy caused by placement of the airway adjunct. The order of the scans (with and without airway adjunct) will be determined by randomization software in advance.
Healthy volunteers will self-place either the ManMaxAirway oropharyngeal airway adjunct or the Guedel Oropharyngeal airway adjunct, which will be left in place for an interval of one minute, while supervised by research staff. After completing a questionnaire and resting for a timed interval, they will then self-place the other airway adjunct, which will be left in place for the same length of time as the first, before completing another questionnaire. The order in which the devices are placed by each subject will be determined in advance via computer randomization.
Volunteers from the tolerability comparison arm will also be invited as a subset of subjects to participate in a measurement of resistance to forced oscillation. The volunteers will be subject to forced oscillations in a pulmonary function lab with the ManMaxAirway oropharyngeal airway adjunct in place and with no airway adjunct in order to observe changes in resistance to oscillatory airflow