We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01800344
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : February 27, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events Device: LMA Device: Ultra Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events: A Prospective, Randomized Trial
Study Start Date : January 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Active Comparator: The laryngeal mask airway-ClassicTM (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.
Device: LMA
Other Name: The laryngeal mask airway-Classic

Active Comparator: The AES Ultra CPVTM LMA (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
Device: Ultra
Ultra
Other Name: AES Ultra CPVTM LMA (Ultra)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Intracuff pressure [ Time Frame: intraoperative ]
    Intracuff pressure intraoperative 10 post insertion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800344


Locations
Layout table for location information
Canada, Ontario
Univeristy Health Network- Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01800344    
Other Study ID Numbers: 11-0392-A
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013
Keywords provided by University Health Network, Toronto:
Airway Cuff
LMA
Ultra
Cuff Pressure
Ventilation
Anesthesia
Intubation