Articulated Oral Airway for Non-Invasive Ventilation

N/A

Waitlist Available

Led By Ron O Abrons, MD

Research Sponsored by Ron Abrons

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured immediately after removal of first oral airway and before placing the second oral airway

Awards & highlights

No Placebo-Only Group

Summary

The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The investigators hypothesize that, in patients with predictors for difficult mask ventilation, the AOA will be non-inferior to the Geudel oral airway in terms of expired tidal volumes.

Eligible Conditions

Upper Airway Obstruction
Non-Invasive Ventilation
Airway Management

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured immediately after placement of each oral airway; an average of 2-5 minutes.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured immediately after placement of each oral airway; an average of 2-5 minutes.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured immediately after placement of each oral airway; an average of 2-5 minutes. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Expiratory Tidal Volume (Breaths 6-10)

Secondary study objectives

Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First

Inspiratory Tidal Volume (Breaths 6-10)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Articulated Oral AirwayExperimental Treatment1 Intervention

Each participant in the study will have both devices (GOA or AOA). The participants reported in this arm were randomized to receive the Articulated oral airway first and measurements were taken during breaths 6 through 10. After its removal the Guedel Oral Airway was inserted and measurements were repeated again during breaths 6 through 10.

Group II: Guedel oral airwayActive Control1 Intervention

Each participant in the study will have both devices (GOA or AOA). The participants reported in this arm were randomized to receive the Guedel oral airway first and measurements were taken during breaths 6 through 10. After its removal the Articulated Oral Airway was inserted and measurements were repeated again during breaths 6 through 10.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Articulated Oral Airway

2017

N/A

~60

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