Laryngeal MasksOLP-Aur/SupNCT02816463
RCT:Oropharyngeal Leak Pressure (OLP) - Ambu AuraGain vs LMA Supreme
A study testing Ambu AuraGain and LMA Supreme in people with Laryngeal Masks, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Masks
- What is being tested?
- Ambu AuraGain and LMA Supreme
- 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
- Jun 2016to 9 May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I to III Adults more above 18 years Ambulatory surgeries under general anesthesia in supine position requiring laryngeal masks- Knee arthroscopies, bladder tumour resections, hand, eye and general surgical procedures Muscle relaxant not required
Who cannot join
- Reduced mouth opening less than 2.5 cms Recent upper respiratory tract infection and sore throat in last 2 weeks Contraindications to laryngeal mask use as in morbid obesity- BMI more than 40 and severe symptomatic esophageal reflux disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Oropharyngeal Leak Pressure Between the Ambu AuraGain and the LMA Supreme - a Prospective Randomized Trial
The purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak pressure is the pressure at which a gas leaks around the airway, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway.
- Conditions
- Laryngeal Masks
- Being tested
- Ambu AuraGain, LMA Supreme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu AuraGainDevice
LMA SupremeDevice
| Study group | Role | What they receive |
|---|---|---|
| Ambu AuraGain (Group A) | Experimental | Laryngeal mask Ambu AuraGain will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure Receives: Device: Ambu AuraGain |
| LMA Supreme (Group S) | Active comparator | Laryngeal mask Supreme will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure Receives: Device: LMA Supreme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure (OLP) for each airway device after insertion
OLP is defined as 'the anesthesia circuit pressure at which a gas leak occurs around the SAD'.
Measured: Within 2-3 minutes after laryngeal mask insertion before start of surgery.
Secondary outcomes (3)
Phrayngolaryngeal complications
Complications like sore throat, dysphonia, dysphagia
Measured: at 1 hr, 2hr and 24 hrs after the surgery
Postoperative nausea and vomiting (PONV)
PONV in the post anesthesia care unit (PACU)- PONV will be recorded as only None for No PONV and Yes for present. Severity grading will not be recorded.
Measured: at 1 hr, 2hr and 24 hrs after the surgery
Satisfaction of patient and the anesthesiologist with the device
Patient satisfaction (5 point scale)- 0 for very dissatisfied to 5 for very satisfied Anesthesiologist satisfaction scale- Low, Moderate and High
Measured: After 1hr in the post anesthesia care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion9 May 2017
- Study completion9 May 2017
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 Laryngeal MasksStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Wong, University Health Network, Toronto
- Investigators
- David T Wong, MD, Principal investigator, Uinversity Health Network (UHN), Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816463
- Sponsor's protocol ID
- 14-8360-B
- Acronym
- OLP-Aur/Sup
- Status last verified
- Jun 2017
- First submitted
- 22 Jun 2016
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wong DT, Ooi A, Singh KP, Dallaire A, Meliana V, Lau J, Chung F, Singh M, Wong J. Comparison of oropharyngeal leak pressure between the Ambu(R) AuraGain and the LMA(R) Supreme supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7):797-805. doi: 10.1007/s12630-018-1120-4. Epub 2018 Mar 26.
PubMed 29582360
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oropharyngeal Leak Pressure Between the Ambu AuraGain and the LMA Supreme - a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02816463
- Acronym / sponsor ID
- OLP-Aur/Sup / 14-8360-B
- Conditions
- Laryngeal Masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 28 Jun 2016 (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 purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak pressure is the pressure at which a gas leaks around the airway, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu AuraGain (Group A) | Experimental | Device: Ambu AuraGainLaryngeal mask Ambu AuraGain will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure |
| LMA Supreme (Group S) | Active comparator | Device: LMA SupremeLaryngeal mask Supreme will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I to III Adults more above 18 years Ambulatory surgeries under general anesthesia in supine position requiring laryngeal masks- Knee arthroscopies, bladder tumour resections, hand, eye and general surgical procedures Muscle relaxant not required
Key exclusion criteria (1 listed)
- Reduced mouth opening less than 2.5 cms Recent upper respiratory tract infection and sore throat in last 2 weeks Contraindications to laryngeal mask use as in morbid obesity- BMI more than 40 and severe symptomatic 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 |
|---|---|---|
| Ambu AuraGain | Device | Ambu AuraGain (Group A) |
| LMA Supreme | Device | LMA Supreme (Group S) |
Primary outcome
Oropharyngeal leak pressure (OLP) for each airway device after insertion
Time frame: Within 2-3 minutes after laryngeal mask insertion before start of surgery.
OLP is defined as 'the anesthesia circuit pressure at which a gas leak occurs around the SAD'.
3 secondary outcomes
Phrayngolaryngeal complications
Time frame: at 1 hr, 2hr and 24 hrs after the surgery
Postoperative nausea and vomiting (PONV)
Time frame: at 1 hr, 2hr and 24 hrs after the surgery
Satisfaction of patient and the anesthesiologist with the device
Time frame: After 1hr in the post anesthesia care unit (PACU)
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 6 Jun 2017.
- Derived from this study: PubMed 29582360Wong DT, Ooi A, Singh KP, Dallaire A, Meliana V, Lau J, Chung F, Singh M, Wong J. Comparison of oropharyngeal leak pressure between the Ambu(R) AuraGain and the LMA(R) Supreme supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7):797-805. doi: 10.1007/s12630-018-1120-4. Epub 2018 Mar 26.
- Individual participant dataSharing planned: No
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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.
David T Wong, MD principal investigator
Uinversity Health Network (UHN), Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu AuraGain and LMA Supreme in people with Laryngeal Masks, 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 1 inclusion and 1 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 6 Jun 2017. 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?
Oropharyngeal leak pressure (OLP) for each airway device after insertion (time frame: Within 2-3 minutes after laryngeal mask insertion before start of surgery.). 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 NCT02816463, 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 6 Jun 2017.