Performance and Safety of a New Supraglottic Airway DevicePhase 2NCT01496859
Observational Study of Baska Mask, a New Supraglottic Airway Device
A Phase 2 study testing Placement and use of Baska mask in people with Performance and Safety of a New Supraglottic Airway Device, run by University College Hospital Galway at 1 site in Ireland.
Trial summary
The Baska mask is a new supraglottic airway device . The investigators would like to assess its performance in setting in which the current standard - LMA device - is being used. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Performance and Safety of a New Supraglottic Airway Device
- What is being tested?
- Placement and use of Baska mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2011to Dec 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed Consent
- No relevant drug allergies
- Body-mass index (BMI) 20-35
- Age 18-65
- Non-urgent surgery of planned duration 0-2 hrs
Who cannot join
- Inability of patient/parent to understand or consent for the trial
- Non-English speakers
- Neck pathology
- Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days etc)
- BMI >35
- Expected Difficult airway
- Live Pregnancy
- Increased risk for Gastric Aspiration
Trial locations and contacts
1 site in 1 country.
About this study
The Baska mask is a new supraglottic airway device . The investigators would like to assess its performance in setting in which the current standard - LMA device - is being used.
Read the detailed description
Our group has performed a number of studies on novel airway devices. In this study we would like to evaluate a new supraglottic airway named Baska mask. We would like to monitor certain parameters (time to and ease of insertion, failure rate, seal pressures, complications etc) as regarding the performance and safety profile of this device. This is a descriptive case series of patients undergoing airway management under general anaesthesia.
- Being tested
- Placement and use of Baska mask
- Keywords
- Baska mask, supraglottic airway, airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement and use of Baska maskDevice
Also called Baska mask
use of a supraglottic airway device as a standard part of a general anaesthetic
| Study group | Role | What they receive |
|---|---|---|
| Baska | Experimental | Not described Receives: Device: Placement and use of Baska mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Placement Success rate
Measured: within 30 mins of anaesthesia commencement
time to placement of device
from the moment the device touched until successful ventilation achieved or device removed
Measured: within 30 mins of anaesthesia commencement
Secondary outcomes (4)
airway leak pressure of the device
Measured: within 30 mins of anaesthetic commencement
user-rated ease of insertion of device
10cm visual analog score to be used
Measured: within 30 mins of anaestesia commencement
complication rates
complications specifically monitored will be desaturation episodes, laryngospasm, blood staining of the device, lip damage. We will record other complications related to the use of the device, including but not limited to loss of airway with need to manioulate mask/switch to alternative device, regurgitation, aspiration, teeth damage.
Measured: From the moment general anaesthesia commenced up to 1 day postoperatively
patient comfort indices
Throat pain, dysphagia and dysphonia will be assessed. 10 point verbal rating scale will be used
Measured: from the moment the patient awake up to 1 day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance and Safety of a New Supraglottic Airway DeviceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Laffey, University College Hospital Galway
- Investigators
- John G Laffey, FFARCSI, Principal investigator, National University of Ireland, Galway and Galway University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496859
- Sponsor's protocol ID
- C.A.621
- Status last verified
- Mar 2012
- First submitted
- 18 Dec 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Baska Mask, a New Supraglottic Airway Device
- ClinicalTrials.gov ID
- NCT01496859
- Acronym / sponsor ID
- C.A.621
- Keywords
- Baska mask, supraglottic airway, airway management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Dec 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.
The Baska mask is a new supraglottic airway device . The investigators would like to assess its performance in setting in which the current standard - LMA device - is being used.
Detailed description
Our group has performed a number of studies on novel airway devices. In this study we would like to evaluate a new supraglottic airway named Baska mask. We would like to monitor certain parameters (time to and ease of insertion, failure rate, seal pressures, complications etc) as regarding the performance and safety profile of this device. This is a descriptive case series of patients undergoing airway management under general anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baska | Experimental | Device: Placement and use of Baska mask |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed Consent
- No relevant drug allergies
- Body-mass index (BMI) 20-35
- Age 18-65
- Non-urgent surgery of planned duration 0-2 hrs
Key exclusion criteria (8 listed)
- Inability of patient/parent to understand or consent for the trial
- Non-English speakers
- Neck pathology
- Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days etc)
- 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 |
|---|---|---|
| Placement and use of Baska maskAlso: Baska maskuse of a supraglottic airway device as a standard part of a general anaesthetic | Device | Baska |
Primary outcome
Device Placement Success rate
Time frame: within 30 mins of anaesthesia commencement
time to placement of device
Time frame: within 30 mins of anaesthesia commencement
from the moment the device touched until successful ventilation achieved or device removed
4 secondary outcomes
airway leak pressure of the device
Time frame: within 30 mins of anaesthetic commencement
user-rated ease of insertion of device
Time frame: within 30 mins of anaestesia commencement
complication rates
Time frame: From the moment general anaesthesia commenced up to 1 day postoperatively
patient comfort indices
Time frame: from the moment the patient awake up to 1 day postoperatively
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 26 Mar 2012.
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.
John G Laffey, FFARCSI principal investigator
National University of Ireland, Galway and Galway University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Placement and use of Baska mask in people with Performance and Safety of a New Supraglottic Airway Device, run by University College Hospital Galway at 1 site in Ireland.
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 5 inclusion and 8 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 26 Mar 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 Ireland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Device Placement Success rate (time frame: within 30 mins of anaesthesia commencement). The study lists 2 primary outcomes in all. 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 26 Mar 2012.