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

Not Applicable

Completed

• Conditions: The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events
• Interventions: Device: LMA; Device: Ultra

• Registration Number: NCT01800344
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-02
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-25
• Last Update Submitted: 2013-02-25
• Study First Posted: 2013-02-27
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The laryngeal mask airway-ClassicTM (LMA)	LMA	The LMA is a large foreign body that exerts pressure on the pharyngeal mucosa. High LMA intracuff pressures may reduce pharyngeal mucosal perfusion and lead to throat discomfort.
The AES Ultra CPVTM LMA (Ultra)	Ultra	Ultra is a new supraglottic airway with anatomical features and insertion technique virtually identical to the LMA-ClassicTM. The cuff and the shaft are made of silicone with a built-in CPV pilot balloon valve which provides continuous monitoring of the intracuff pressure. The CPV cuff pressure indicator has 3 zones indicated by color: yellow corresponds to pressure \< 50 cm H2O; green 60 cm H2O; and red \>70 cm H2O

Primary Outcome Measures

Name	Time	Method
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.	1, 2, 24 hours

Secondary Outcome Measures

Name	Time	Method
Intracuff pressure	intraoperative	Intracuff pressure intraoperative 10 post insertion

Trial Locations

Locations (1)

Univeristy Health Network- Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada