Investigation of a Novel Oropharyngeal Airway: The ManMaxAirway

NCT03969147 | Unknown

• 1 other identifier: CHRMS 16-105
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Guedel pattern or oropharyngeal airways (OPA) maintain an open oral airway in unconscious or semi-conscious patients by preventing the tongue from covering the epiglottis, but OPA placement carries a risk of inducing gag reflex and vomiting. Although various sizes are available, the design of the OPA has undergone little change since its introduction in the 1920s. The purpose of this study is to determine the utility of a novel airway device, the ManMaxAirway (MMA), as an alternative to the OPA.

Conditions

Airway Obstruction; Respiratory Complication

Outcome Measures

Primary Outcomes (1)

• Ability to place the Novel Airway Adjunct

  Any inability of conscious, healthy volunteers to place the device (MMA) in their mouth will be recorded.

  1 minute (During tolerability comparison experiment)

Secondary Outcomes (5)

• Displacement of the mandibular condyle and the condylar fossa apex (MRI arm)

  2-3 weeks following MRI scans.

• Number of respirations with airway adjunct in place (Tolerability Arm)

  1 minute (During tolerability comparison experiment)

• Elapsed time (up to 60 seconds) that subject is able to tolerate having the airway adjunct in place (Tolerability Arm)

  1 minute (During tolerability comparison experiment.)

• Visual Analog Tolerability

  1 minute (following tolerability comparison experiment.)

• Resistance to oscillatory air flow

  1 minute (Assessment done following physical lab tests)

Study Arms (3)

MRI Comparison

ACTIVE COMPARATOR

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.

Device: ManMaxAirway oropharyngeal airway adjunct; Device: No airway adjunct

Tolerability Comparison

EXPERIMENTAL

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.

Device: ManMaxAirway oropharyngeal airway adjunct; Device: Guedel Oropharyngeal airway adjunct

Forced Oscillation

ACTIVE COMPARATOR

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

Device: ManMaxAirway oropharyngeal airway adjunct; Device: No airway adjunct

Interventions

ManMaxAirway oropharyngeal airway adjunct DEVICE

Healthy volunteers will self-place the ManMaxAirway.

Forced Oscillation; MRI Comparison; Tolerability Comparison

Guedel Oropharyngeal airway adjunct DEVICE

Healthy volunteers will self-place the standard Guedel OPA.

Tolerability Comparison

No airway adjunct DEVICE

Healthy volunteers will have no airway adjunct in place.

Forced Oscillation; MRI Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers over the age of 18.

You may not qualify if:

• For Tolerability arm: History of Gastroesophageal Reflux Disease, dental implants or dental prostheses

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Kalev Freeman, MD, PhD

  University of Vermont Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary Miller, BA

CONTACT

8026568372; zdmiller@uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: May 31, 2019
• Study Start: May 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)