A New Flexible Extended-Length Pharyngeal Airway for Deep Sedation

NCT ID: NCT04419883

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-05
• Study Completion Date: 2020-05-05

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.

Detailed 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.

Conditions

Upper Airway Obstruction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Anesthesia Providers

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

McMurray Enhanced Airway

Intervention Type: DEVICE

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

Interventions

McMurray Enhanced Airway

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

Intervention Type: DEVICE

Other Intervention Names

MEA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMurray Medical Group, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Roxanne R McMurray

VP of Clinical Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roxanne McMurray, DNP

Role: PRINCIPAL_INVESTIGATOR

McMurray Medical Group, LLC

Locations

Roxanne McMurray

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

MEA-001-01

Identifier Type: -

Identifier Source: org_study_id