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

University Health Network, Toronto

Status: Completed

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

Treatments: Device: LMA; Device: Ultra

Study type: Interventional

Funder types: Other

Identifiers

NCT01800344

11-0392-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

170 participants in 2 patient groups

The laryngeal mask airway-ClassicTM (LMA)

Active Comparator group

Description:

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.

Treatment:

Device: LMA

The AES Ultra CPVTM LMA (Ultra)

Active Comparator group

Description:

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

Treatment:

Device: Ultra