Airway MorbidityNCT02458794
Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM
A study testing function tests, LMA SupremeTM and Ambu-Aura GainTM in people with Airway Morbidity, run by Schulthess Klinik at 2 sites in 2 countries.
Trial summary
The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- function tests, LMA SupremeTM and Ambu-Aura GainTM
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2015to Apr 2016
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 or 2
- Age 19-65 yr
- Written informed consent
Who cannot join
- Difficult airway
- Non fasted
- BMI > 35
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Zentralkrankenhaus Bozen
Bolzano, 39100
Lukas Gasteiger, MD, Lukas.Gasteiger@sabes.it
Switzerland1 site
Schulthess Klinik
Zurich, 8008
Christian Keller, MD, M.Sc., +41443857462, christian.keller@kws.ch
About this study
Official title: A Randomized Crossover Study of the LMA SupremeTM Versus Ambu-Aura GainTM in Adult Patients
The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.
- Conditions
- Airway Morbidity
- Being tested
- function tests, LMA SupremeTM, Ambu-Aura GainTM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
function testsProcedure or surgery
ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
LMA SupremeTMDevice
Ambu-Aura GainTMDevice
| Study group | Role | What they receive |
|---|---|---|
| LMA SupremeTM | Active comparator | function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion Receives: Procedure: function tests; Device: LMA SupremeTM |
| Ambu-Aura GainTM | Active comparator | function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion Receives: Procedure: function tests; Device: Ambu-Aura GainTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
oropharyngeal seal pressure
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).
Measured: 5 minutes
Secondary outcomes (1)
anatomic position
The anatomic position was assessed by passing a fiberoptic scope through the airway tube stopping 0,5 cm prior to the end of the tube. The airway tube view was scored using an established scoring system.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenhaus Bozen
- Responsible party
- Sponsor
- Investigators
- Christian Keller, MD MSc, Study chair, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458794
- Sponsor's protocol ID
- Schulthess_Anä_5
- Status last verified
- Jul 2015
- First submitted
- 20 May 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study of the LMA SupremeTM Versus Ambu-Aura GainTM in Adult Patients
- ClinicalTrials.gov ID
- NCT02458794
- Acronym / sponsor ID
- Schulthess_Anä_5
- Conditions
- Airway Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- Krankenhaus Bozen
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 1 Jun 2015 (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 Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA SupremeTM | Active comparator | Procedure: function tests, Device: LMA SupremeTMfunction tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion |
| Ambu-Aura GainTM | Active comparator | Procedure: function tests, Device: Ambu-Aura GainTMfunction tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1 or 2
- Age 19-65 yr
- Written informed consent
Key exclusion criteria (3 listed)
- Difficult airway
- Non fasted
- BMI > 35
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 |
|---|---|---|
| function testsease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion | Procedure or surgery | Ambu-Aura GainTM, LMA SupremeTM |
| LMA SupremeTM | Device | LMA SupremeTM |
| Ambu-Aura GainTM | Device | Ambu-Aura GainTM |
Primary outcome
oropharyngeal seal pressure
Time frame: 5 minutes
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).
1 secondary outcome
anatomic position
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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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.
Christian Keller, MD MSc study chair
Schulthess Klinik
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing function tests, LMA SupremeTM and Ambu-Aura GainTM in people with Airway Morbidity, run by Schulthess Klinik at 2 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Switzerland. 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 Christian Keller, MD MSc (++41443857462, christian.keller@kws.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oropharyngeal seal pressure (time frame: 5 minutes). 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 29 Jul 2015.