The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator

University Health Network, Toronto170 enrolled

Overview

The study compares the incidence of pharyngolaryngeal complications in patients managed with either a pressure-limiting strategy using the AES Ultra CPVTM or a standard practice using a LMA, in ambulatory surgery patients.

Recent evidence suggests that reduction of LMA intracuff pressure may decrease the incidence of pharyngolaryngeal symptoms. Yet, pressure manometers are not widely available limiting the application of a strategy of intracuff pressure reduction. The Ultra airway has been designed to provide continuous indication of intracuff pressure and can limit the intracuff pressure to \< 60 cm H2O. This study compares the incidence of pharyngolaryngeal complications in patients managed with either a pressure-limiting strategy using the Ultra or a standard practice using a LMA, in ambulatory surgery patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

170

Conditions

The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events

Interventions

LMADEVICE

UltraDEVICE

Ultra

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * American Society of Anesthesiologists physical status I-III * 18 to 65 years of age * Ambulatory patients scheduled to undergo knee arthroscopy, transurethral resection of bladder tumor, hand, gynecological, general surgical and eye procedures under a short general anesthesia of less than 2 hours * Spontaneously breathing on the LMA Exclusion Criteria: * Reduced mouth opening less than 2.5cm * Recent history of upper respiratory tract infection and sore throats * Contraindications of LMA use (Morbid obesity with body mass index greater than 40kg/m2, symptomatic hiatus hernia, esophageal reflux disease)

Locations (1)

Univeristy Health Network- Toronto Western Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

The primary outcome, composite pharyngolaryngeal complication, is defined as the presence of either sore throat, dysphonia or dysphagia at 1, 2, and 24 h postoperatively.

Time frame: 1, 2, 24 hours

Secondary Outcomes

Intracuff pressure

Intracuff pressure intraoperative 10 post insertion

Time frame: intraoperative

Data from ClinicalTrials.gov

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