Adverse Anesthesia OutcomePhase 3NCT01575236
A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway
A Phase 3 study testing Guardian Laryngeal Mask and Supreme Laryngeal Mask Airway in people with Adverse Anesthesia Outcome, run by Schulthess Klinik at 1 site in Austria.
Trial summary
The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Adverse Anesthesia Outcome
- What is being tested?
- Guardian Laryngeal Mask and Supreme Laryngeal Mask Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2012to Jul 2012
- Phase
- Phase 3
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 or 2
- Age 18-75 yr
- Written informed consent
Who cannot join
- Difficult airway
- Non fasted
- BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.
Read the detailed description
The GuardianTM 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, non-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 GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- Guardian Laryngeal Mask, Supreme Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardian Laryngeal MaskDevice
Also called Guardian Laryngeal Mask, Umedaes
ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion
Supreme Laryngeal Mask AirwayDevice
Also called Supreme Laryngeal Mask Airway, LMA Deutschland GmbH
ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion
| Study group | Role | What they receive |
|---|---|---|
| Guardian | Experimental | Guardian Laryngeal Mask Receives: Device: Guardian Laryngeal Mask |
| Supreme | Experimental | Supreme Laryngeal Mask Airway Receives: Device: Supreme Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of oropharyngeal seal pressure
this will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O
Measured: 5 min
Secondary outcomes (1)
anatomic position
this will be determined fiberoptically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Anesthesia OutcomeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
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 MSc, Study chair, Anästhesie Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575236
- Sponsor's protocol ID
- Schulthess_Anä_3
- Other IDs
- Schulthess_Anä_3
- Status last verified
- Aug 2012
- First submitted
- 30 Mar 2012
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT01575236
- Acronym / sponsor ID
- Schulthess_Anä_3
- Conditions
- Adverse Anesthesia Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Apr 2012 (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 investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.
Detailed description
The GuardianTM 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, non-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 GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guardian | Experimental | Device: Guardian Laryngeal MaskGuardian Laryngeal Mask |
| Supreme | Experimental | Device: Supreme Laryngeal Mask AirwaySupreme Laryngeal Mask Airway |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1 or 2
- Age 18-75 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 |
|---|---|---|
| Guardian Laryngeal MaskAlso: Guardian Laryngeal Mask, Umedaesease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion | Device | Guardian |
| Supreme Laryngeal Mask AirwayAlso: Supreme Laryngeal Mask Airway, LMA Deutschland GmbHease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion | Device | Supreme |
Primary outcome
efficacy of oropharyngeal seal pressure
Time frame: 5 min
this will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O
1 secondary outcome
anatomic position
Time frame: 5 min
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 8 Aug 2012.
Related trials for Adverse Anesthesia Outcome
RecruitingPhase 4
Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery
Analgesics, Opioid, Anesthesia, Spinal
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
Anästhesie Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Guardian Laryngeal Mask and Supreme Laryngeal Mask Airway in people with Adverse Anesthesia Outcome, run by Schulthess Klinik at 1 site in Austria.
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: finished, as of the sponsor's last update on 8 Aug 2012. 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 Austria. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
efficacy of oropharyngeal seal pressure (time frame: 5 min). 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 8 Aug 2012.