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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01800344

Enrollment

170

Registered

2013-02-27

Start date

2012-01-31

Completion date

2012-10-31

Last updated

2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Airway Cuff, LMA, Ultra, Cuff Pressure, Ventilation, Anesthesia, Intubation

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.

Interventions

DEVICELMA

DEVICEUltra

Ultra

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
Intracuff pressure	intraoperative	Intracuff pressure intraoperative 10 post insertion

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026