A New Flexible Extended-Length Pharyngeal Airway for Deep Sedation

NCT04419883 | Completed FDA Device

• 1 other identifier: MEA-001-01
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective pilot provider adoption study was to evaluate user experience a new airway device in adult patients with airway obstruction under deep sedation. Fifteen hospital systems served as testing sites. Fifty-four anaesthetist providers reported their experience with the airway device in 84 cases across two phases of surveying.

Conditions

Upper Airway Obstruction

Keywords

Upper airway obstruction; Airway management tools; Airway complications; Deep sedation; Deep monitored anaesthesia care (MAC)

Outcome Measures

Primary Outcomes (3)

• Evaluate the new, flexible extended-length pharyngeal airway ease of use

  The question asked: With the curve end facing the hard palate, how easy was the MEA to place? Four response options on measurement tool to assess outcomes: Easy, Moderate, Difficult, Not Successful

  Survey was completed immediately after completion of surgery and airway use

• Assess the new, flexible extended-length pharyngeal ability to relieve an upper airway obstruction

  Two response options on measurement tool to assess outcomes: Yes and No

  Survey was completed immediately after completion of surgery and airway use

• Assess if the new airway allowed a "hands off approach" when the patient was under deep sedation/MAC anesthesia

  Three response options on measurement tool to assess outcomes: Yes, No, Not sure

  Survey was completed immediately after completion of surgery and airway use

Secondary Outcomes (1)

• Provider satisfaction with the new, flexible extended-length pharyngeal airway.

  Survey was completed immediately after completion of surgery and airway use

Study Arms (1)

Anesthesia Providers

Anesthesia providers from 15 different health care facilities in the United States.

Device: McMurray Enhanced Airway

Interventions

McMurray Enhanced Airway DEVICE

Provider Satisfaction of a New, Flexible Extended-Length Pharyngeal Airway to Relieve Upper Airway Obstructive During Deep Sedation: A Pilot Study

Also known as: MEA

Anesthesia Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anesthesia providers who volunteered to trial this new airway device were recruited to complete a survey tool to assess provider satisfaction of a commercially-available upper airway device (McMurray Enhanced Airway (MEA); McMurray Medical, Minneapolis, MN).

You may qualify if:

• years of age and older
• Scheduled for surgery with sedation/MAC anesthesia
• Patients experiencing an obstructive airway needing an airway device placed

You may not qualify if:

• Inappropriate airway device size, too big or too small

Sponsors & Collaborators

• McMurray Medical Group, LLC: lead

Study Sites (1)

Roxanne McMurray

Minneapolis, Minnesota, 55432, United States

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Roxanne McMurray, DNP

  McMurray Medical Group, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VP of Clinical Management

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 9, 2020
• Study Start: March 5, 2019
• Primary Completion: March 5, 2020
• Study Completion: May 5, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)