Device Induced InjuryNCT01367678
Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients
A study testing Laryngeal Mask Airway Supreme and i-Gel extraglottic airway device in people with Device Induced Injury and Necrosis, Pressure, run by Schulthess Klinik at 2 sites in 2 countries.
Trial summary
In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized females. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Device Induced Injury, Necrosis, Pressure, Complication of Device Insertion
- What is being tested?
- Laryngeal Mask Airway Supreme and i-Gel extraglottic airway device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2011to Aug 2011
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I/II
- female
- age 19-65 years
Who cannot join
- < 19 years
- had a known or predicted difficult airway
- a body mass index > 35 kg m-2, or
- were at risk of aspiration
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices
In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized females.
Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx; C, hypopharynx; and D, pyriform fossa.
Insertion success rate and oropharyngeal leak pressure were also measured.
- Conditions
- Device Induced Injury, Necrosis, Pressure, Complication of Device Insertion, Airway Morbidity
- Being tested
- Laryngeal Mask Airway Supreme, i-Gel extraglottic airway device
- Medical subject headings
- Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask Airway SupremeDevice
Also called Supreme
Directly measured mucosal pressures
i-Gel extraglottic airway deviceDevice
Also called i-Gel
Directly measured mucosal pressures
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal Mask Airway Supreme | Experimental | Directly measured mucosal pressures Receives: Device: Laryngeal Mask Airway Supreme |
| i-Gel | Experimental | Directly measured mucosal pressures Receives: Device: i-Gel extraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharyngeal mucosal pressure
Measured: every 5 minutes during steady state anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device Induced InjuryStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Principal investigator, ChristianKeller, Schulthess Klinik
- Investigators
- Christian Keller, MD, M.Sc., Study director, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367678
- Sponsor's protocol ID
- Schulthess_Anä_1
- Status last verified
- Aug 2011
- First submitted
- 3 Jun 2011
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices
- ClinicalTrials.gov ID
- NCT01367678
- Acronym / sponsor ID
- Schulthess_Anä_1
- Conditions
- Device Induced Injury, Necrosis, Pressure, Complication of Device Insertion, Airway Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Jun 2011 (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.
In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized females.
Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx; C, hypopharynx; and D, pyriform fossa.
Insertion success rate and oropharyngeal leak pressure were also measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Mask Airway Supreme | Experimental | Device: Laryngeal Mask Airway SupremeDirectly measured mucosal pressures |
| i-Gel | Experimental | Device: i-Gel extraglottic airway deviceDirectly measured mucosal pressures |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I/II
- female
- age 19-65 years
Key exclusion criteria (4 listed)
- < 19 years
- had a known or predicted difficult airway
- a body mass index > 35 kg m-2, or
- were at risk of aspiration
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 |
|---|---|---|
| Laryngeal Mask Airway SupremeAlso: SupremeDirectly measured mucosal pressures | Device | Laryngeal Mask Airway Supreme |
| i-Gel extraglottic airway deviceAlso: i-GelDirectly measured mucosal pressures | Device | i-Gel |
Primary outcome
pharyngeal mucosal pressure
Time frame: every 5 minutes during steady state anesthesia
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 24 Aug 2011.
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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, M.Sc. study director
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 Laryngeal Mask Airway Supreme and i-Gel extraglottic airway device in people with Device Induced Injury and Necrosis, Pressure, 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 4 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 24 Aug 2011. 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 Austria, 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?
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?
pharyngeal mucosal pressure (time frame: every 5 minutes during steady state anesthesia). 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 24 Aug 2011.