Determination of the Best Predictor for Correct Baska Mask SizePhase 2NCT01625052
Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients
A Phase 2 study testing Placement and use of Baska mask in people with Determination of the Best Predictor for Correct Baska Mask Size, run by University College Hospital Galway at 1 site in Ireland.
Trial summary
The investigators group has performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask. Read more about this study
- Who is it for?
- Ages 16 to 85 years, men only
- Conditions the study is for
- Determination of the Best Predictor for Correct Baska Mask Size
- 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
- 50 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2012to Jun 2012
- 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 16 to 85 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male
- Written informed consent
- ASA 1-3
- No relevant allergies
- Body-mass index (BMI) 20-35
- Age 16-85
- Non-urgent surgery of planned duration 0.25-4 hrs
Who cannot join
- Inability of patient/parent to understand or consent for the trial
- 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)
- BMI > 35
- Predicted or previously documented difficult airway
- Increased risk for Gastric Aspiration
- Current participation in another Clinical Study
Trial locations and contacts
1 site in 1 country.
About this study
The investigators group has performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask. In this new study the investigators wish to determine which criteria best predict the correct size of the Baska mask to be used in male patients
Read the detailed description
Our observational study of the performance of the Baska mask suggests that this novel supraglottic airway has promise as an alternative to the current standard device, the laryngeal mask airway (LMA). Our results indicate that while the manufacturer weight criteria work reasonably well in females this may not be the case in males. The investigators wish to determine how well the manufacturer recommended sizing criteria for the Baska mask work in males.
This study is designed to determine which criteria best predict the correct size Baska mask to use in male patients. In addition the investigators will monitor the performance and safety of this device (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc)
- Being tested
- Placement and use of Baska mask
- Keywords
- mask size, 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
use of Baska mask as component of standard 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.
Determination of the best predictor for successful Baska mask size
We will evaluate the correlation between certain patient characteristics (including, but not limited, to actual and ideal body weight; height) and the size of the Baska mask used successfully in each patient.
Measured: From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours.
Secondary outcomes (6)
insertion success rate of the device
Measured: within 30 min of anaesthesia commencement
device airway leak pressure
Measured: within 30 min of anaesthesia commencement
device insertion time
the time from the moment the device is touched until successful ventilation is achieved or device is removed.
Measured: within 30 min of anaesthesia commencement
ease of insertion of device
we will use 10cm visual analogue scale
Measured: within 30 min of anaesthesia commencement
complications
Complications during insertion, maintenance and removal and in the postoperative period (in PACU and next day follow up) List of complications (not exhaustive): desaturation episodes, loss of airway with need to manipulate mask/switch to alternative device, lip/teeth damage, regurgitation, aspiration, laryngospasm, blood staining on mask removal)
Measured: from the moment anaesthesia commenced up to the first postoperative day, an expected average of 30 hours.
Patient comfort
We will record throat pain, dysphonia and dysphagia using 10 point verbal rating scale.
Measured: from the moment patient awake up to third postoperative day, an expected average of 80 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determination of the Best Predictor for Correct Baska Mask SizeStudies 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
- 50 participants (estimated)
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
- NCT01625052
- Sponsor's protocol ID
- C.A.653
- Status last verified
- Dec 2012
- First submitted
- 23 Mar 2012
- Last updated
- 25 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients
- ClinicalTrials.gov ID
- NCT01625052
- Acronym / sponsor ID
- C.A.653
- Keywords
- mask size, Baska mask, supraglottic airway, airway management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Jun 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 group has performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask. In this new study the investigators wish to determine which criteria best predict the correct size of the Baska mask to be used in male patients
Detailed description
Our observational study of the performance of the Baska mask suggests that this novel supraglottic airway has promise as an alternative to the current standard device, the laryngeal mask airway (LMA). Our results indicate that while the manufacturer weight criteria work reasonably well in females this may not be the case in males. The investigators wish to determine how well the manufacturer recommended sizing criteria for the Baska mask work in males.
This study is designed to determine which criteria best predict the correct size Baska mask to use in male patients. In addition the investigators will monitor the performance and safety of this device (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc)
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
- 16 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male
- Written informed consent
- ASA 1-3
- No relevant allergies
- Body-mass index (BMI) 20-35
Key exclusion criteria (7 listed)
- Inability of patient/parent to understand or consent for the trial
- 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)
- BMI > 35
- Predicted or previously documented difficult airway
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 maskuse of Baska mask as component of standard general anaesthetic | Device | Baska |
Primary outcome
Determination of the best predictor for successful Baska mask size
Time frame: From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours.
We will evaluate the correlation between certain patient characteristics (including, but not limited, to actual and ideal body weight; height) and the size of the Baska mask used successfully in each patient.
6 secondary outcomes
insertion success rate of the device
Time frame: within 30 min of anaesthesia commencement
device airway leak pressure
Time frame: within 30 min of anaesthesia commencement
device insertion time
Time frame: within 30 min of anaesthesia commencement
ease of insertion of device
Time frame: within 30 min of anaesthesia commencement
complications
Time frame: from the moment anaesthesia commenced up to the first postoperative day, an expected average of 30 hours.
Patient comfort
Time frame: from the moment patient awake up to third postoperative day, an expected average of 80 hours.
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 25 Dec 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 Determination of the Best Predictor for Correct Baska Mask Size, 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 7 inclusion and 7 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 25 Dec 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?
Determination of the best predictor for successful Baska mask size (time frame: From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours.). 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 25 Dec 2012.