Supraglottic AirwayNCT03108391
A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients
A study testing Ambu AuraGain and LMA Supreme in people with Supraglottic Airway, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Supraglottic Airway
- 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists Ⅰ-Ⅲ classification
- Patients evaluated as eligible for a LMA
- Body Mass Index ≤35kg/m2
Who cannot join
- Patients with known or predicted difficult airway
- Active respiratory infection
- Risk of aspiration
- Head and neck surgery
- Emergent surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ChineseAMS
Beijing, Beijing Municipality, 100144
Liu Juhui, MD
About this study
The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.
Read the detailed description
Ambu AuraGain Laryngeal Mask Airway is a newly designed supraglottic device. We design this study to test its clinical performance in normal airway patients, in comparison with LMA Supreme.
- Conditions
- Supraglottic Airway
- 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 | Experimental | Subjects will receive the Ambu AuraGain size 3 to size 5 based on manufacturer guidelines Receives: Device: Ambu AuraGain |
| LMA Supreme | Active comparator | Subjects will receive the LMA Supreme size 3 to size 5 based on manufacturer guidelines Receives: Device: LMA Supreme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
The airway pressure at which an airway leak is observed after successful placement of the device
Measured: Up to 1 minute after the time of confirmed device placement
Secondary outcomes (4)
Insertion time
Time needed to insert the device
Measured: Up to 1 minute on each insertion attempt
Ease of insertion
Number of attempts to place the device
Measured: Up to 1 minute on each insertion attempt
Fiberoptic Grade of Laryngeal View
Fiberoptic Grade of Laryngeal View through each device will be graded using a previously grading system
Measured: Up to 1 minute after placement of device
Postoperative Complications
Patient will be evaluated for sore throat, dysphonia, stridor, dysphagia, blood stain on device
Measured: 2 hours after removal of the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Jan 2017
- Primary completion31 Oct 2017 (estimated)
- Study completion31 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic AirwayStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parellel Assignment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhui Liu, Chinese Academy of Medical Sciences
- Investigators
- Liu Juhui, MD, Principal investigator, Plastic Surgery Hospital, ChineseAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108391
- Sponsor's protocol ID
- PSH-2016-8
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients
- ClinicalTrials.gov ID
- NCT03108391
- Acronym / sponsor ID
- PSH-2016-8
- Conditions
- Supraglottic Airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Oct 2017 (estimated)
- Study completion
- 31 Oct 2017 (estimated)
- First posted
- 11 Apr 2017 (actual)
- 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 is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.
Detailed description
Ambu AuraGain Laryngeal Mask Airway is a newly designed supraglottic device. We design this study to test its clinical performance in normal airway patients, in comparison with LMA Supreme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parellel Assignment
| Arm | Type | Receives |
|---|---|---|
| Ambu AuraGain | Experimental | Device: Ambu AuraGainSubjects will receive the Ambu AuraGain size 3 to size 5 based on manufacturer guidelines |
| LMA Supreme | Active comparator | Device: LMA SupremeSubjects will receive the LMA Supreme size 3 to size 5 based on manufacturer guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists Ⅰ-Ⅲ classification
- Patients evaluated as eligible for a LMA
- Body Mass Index ≤35kg/m2
Key exclusion criteria (5 listed)
- Patients with known or predicted difficult airway
- Active respiratory infection
- Risk of aspiration
- Head and neck surgery
- Emergent surgery
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 |
| LMA Supreme | Device | LMA Supreme |
Primary outcome
Oropharyngeal leak pressure
Time frame: Up to 1 minute after the time of confirmed device placement
The airway pressure at which an airway leak is observed after successful placement of the device
4 secondary outcomes
Insertion time
Time frame: Up to 1 minute on each insertion attempt
Ease of insertion
Time frame: Up to 1 minute on each insertion attempt
Fiberoptic Grade of Laryngeal View
Time frame: Up to 1 minute after placement of device
Postoperative Complications
Time frame: 2 hours after removal of the device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Liu Juhui, MD principal investigator
Plastic Surgery Hospital, ChineseAMS
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 Supraglottic Airway, run by Chinese Academy of Medical Sciences at 1 site in China.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Apr 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Juhui, MD (+8615210258001, liujuhui2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal leak pressure (time frame: Up to 1 minute after the time of confirmed device placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2017.