The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator
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| ClinicalTrials.gov Identifier: NCT01800344 |
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Recruitment Status :
Completed
First Posted : February 27, 2013
Last Update Posted : February 27, 2013
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Sponsor:
University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto
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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 |
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.
| 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 |
|---|---|
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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.
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Device: LMA
Other Name: The laryngeal mask airway-Classic |
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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
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Device: Ultra
Ultra
Other Name: AES Ultra CPVTM LMA (Ultra) |
Primary Outcome Measures :
- 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 :
- Intracuff pressure [ Time Frame: intraoperative ]Intracuff pressure intraoperative 10 post insertion
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| 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
| 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):
| 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:
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Airway Cuff LMA Ultra Cuff Pressure |
Ventilation Anesthesia Intubation |