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

NCT01800344 | Completed

• 1 other identifier: 11-0392-A
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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.

  1, 2, 24 hours

Secondary Outcomes (1)

• Intracuff pressure

  intraoperative

Study Arms (2)

The laryngeal mask airway-ClassicTM (LMA)

ACTIVE COMPARATOR

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

The AES Ultra CPVTM LMA (Ultra)

ACTIVE COMPARATOR

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

Interventions

LMA DEVICE

Also known as: The laryngeal mask airway-Classic

The laryngeal mask airway-ClassicTM (LMA)

Ultra DEVICE

Ultra

Also known as: AES Ultra CPVTM LMA (Ultra)

The AES Ultra CPVTM LMA (Ultra)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status I-III
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Univeristy Health Network- Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (1)

• Wong DT, Tam AD, Mehta V, Raveendran R, Riad W, Chung FF. New supraglottic airway with built-in pressure indicator decreases postoperative pharyngolaryngeal symptoms: a randomized controlled trial. Can J Anaesth. 2013 Dec;60(12):1197-203. doi: 10.1007/s12630-013-0044-2. Epub 2013 Oct 5.

  PMID: 24097301 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 27, 2013
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

CA (1)