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
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.
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.
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