A New Flexible Extended-Length Pharyngeal Airway for Deep Sedation

Upper Airway Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419883
• Other study ID #: MEA-001-01
• Status: Completed
• Start date: March 5, 2019
• Est. completion date: May 5, 2020

Study information

• Verified date: June 2020
• Source: McMurray Medical Group, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This multi-center proof-of-concept, descriptive, prospective, and observational study was approved by a universal Institutional Review Board (IRB) for Human Subjects Research in March 2019. Anaesthesia 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).

The MEA is a novel upper airway device with numerous enhanced features relative to currently available airway management products (Figure 1). The MEA has longer flexible tubing allowing for displacement of pharyngeal tissue that oral airways are unable to reach, and avoiding the need for chin lift/jaw thrust maneuvers [16]. The smaller diameter helps reduce stimulation and gagging and permits placement alongside an endoscopy bite block. The softer material, similar to that of a nasal airway, allows for ease of insertion and reduces potential oral injury associated with hard plastic oral airways [16]. An elongated cushioned bite block is designed to prevent proximal airway collapse, allow flexibility of molar placement, and decrease the risk of dental damage [16]. An optional connector can be connected to an anesthesia circuit or manual resuscitator, facilitating intraoral ventilation and aiding in situations such as difficult mask ventilation or when oxygen diffusion in the surgical field may present fire risk [16]. Furthermore, the MEA was designed to reduce need for manual stationary maneuvers by providers such as chin lift or jaw thrust, thereby preventing potential provider-patient exposure of airborne droplets and increased staffing.

Providers received device instructions for use (IFU) by training video and printed material to understand how to use and size the MEA. After using the MEA trial device in clinical practice, anaesthesia providers participated in completing the Use Survey Tool based on cases meeting the following criteria: inclusion criteria included adult patients (age >18) experiencing an obstructive airway under deep sedation; exclusion criteria included determining that the device size was inappropriate—too big or small—for the patient, since placing an improper size could be detrimental for the patient.

The initial survey(Phase 1) was developed to evaluate current product usage, general use conditions, deep sedation conditions, general anaesthesia conditions, device performance, and overall device satisfaction using binary responses with option for subjective free response. Based on Phase 1 responses and provider feedback, Phase 2 surveys were limited to questions with ordinal responses that assessed device use satisfaction during deep sedation procedures only. Surveys were distributed with the trial devices. As this was a pilot feasibility study for the new extended pharyngeal airway device, recruitment of provider subjects was based on interest of using a novel airway device to benefit airway management when providing deep sedation in situations where airway obstruction became problematic. Surveys were voluntarily completed by the anaesthesia provider following each use. One provider could complete multiple surveys to represent individual device performance and experience. Information related to patient, provider, and device placement frequency was not collected in order to expedite response rate to learn initial provider experience. Submitted surveys underwent response analysis by an independent statistician. Due to the nature of qualitative data, descriptive statistics were used to summarize study results. No objective measures of device clinical efficacy were collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 5, 2020
• Est. primary completion date: March 5, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age and older

• Scheduled for surgery with sedation/MAC anesthesia

• Patients experiencing an obstructive airway needing an airway device placed

Exclusion Criteria:

• Inappropriate airway device size, too big or too small

Related Conditions & MeSH terms

• Airway Obstruction
• Upper Airway Obstruction

Intervention

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

Locations

Country	Name	City	State
United States	Roxanne McMurray	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
McMurray Medical Group, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Provider satisfaction with the new, flexible extended-length pharyngeal airway.	Five response options on measurement tool to assess outcomes: Very Satisfied, Somewhat Satisfied, Satisfied, Dissatisfied, I did not use the MEA for deep MAC	Survey was completed immediately after completion of surgery and airway use