The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse EventsNCT01800344
The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator
A study testing LMA and Ultra in people with The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events
- What is being tested?
- LMA and Ultra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Univeristy Health Network- Toronto Western Hospital
Toronto, Ontario, M5T2S8
About this study
Official title: The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events: A Prospective, Randomized Trial
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.
Read the 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.
- Being tested
- LMA, Ultra
- Keywords
- Airway Cuff, LMA, Ultra, Cuff Pressure, Ventilation, Anesthesia, Intubation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMADevice
Also called The laryngeal mask airway-Classic
UltraDevice
Also called AES Ultra CPVTM LMA (Ultra)
Ultra
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 2, 24 hours
Secondary outcomes (1)
Intracuff pressure
Intracuff pressure intraoperative 10 post insertion
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse EventsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800344
- Sponsor's protocol ID
- 11-0392-A
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2013
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24097301
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT01800344
- Acronym / sponsor ID
- 11-0392-A
- Keywords
- Airway Cuff, LMA, Ultra, Cuff Pressure, Ventilation, Anesthesia, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The laryngeal mask airway-ClassicTM (LMA) | Active comparator | Device: LMAThe 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. |
| The AES Ultra CPVTM LMA (Ultra) | Active comparator | Device: UltraUltra 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMAAlso: The laryngeal mask airway-Classic | Device | The laryngeal mask airway-ClassicTM (LMA) |
| UltraAlso: AES Ultra CPVTM LMA (Ultra)Ultra | Device | The AES Ultra CPVTM LMA (Ultra) |
Primary outcome
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
1 secondary outcome
Intracuff pressure
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
- Derived from this study: PubMed 24097301Wong 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA and Ultra in people with The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01800344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.