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

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

Official title:

The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events: A Prospective, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800344
• Other study ID #: 11-0392-A
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: February 25, 2013
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: UHN Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

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

Intervention

Device:
• LMA

• Ultra
Ultra

Locations

Country	Name	City	State
Canada	Univeristy Health Network- Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Intracuff pressure	Intracuff pressure intraoperative 10 post insertion	intraoperative	No