Baska Mask Efficacy and Safety in ChildrenPhase 2NCT01625078
Observational Study of Baska Mask, a New Supraglottic Airway Device in Children
A Phase 2 study testing Placement and use of Baska mask in people with Baska Mask Efficacy and Safety in Children, run by John Laffey at 1 site in Ireland.
Trial summary
The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Baska Mask Efficacy and Safety in Children
- 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
- 20 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2012to Jun 2013
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- consent
- BMI 15-35
- weight over 30kg or age 8-16 yrs
- non-urgent surgery of planned duration up to 2 hrs
Who cannot join
- neck pathology
- previous or anticipated problems with the upper GI or upper airway
- increased risk of gastric aspiration
- expected difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.
- Being tested
- Placement and use of Baska mask
- Keywords
- Baska Mask, Supraglottic airway device, Children, Pediatric
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 a supraglottic airway during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Baska mask | 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 insertion success rate
Measured: within 30 minutes of induction of general anesthesia
device airway leak pressure
the airway l;eak pressure is defined as the plateau airway pressure measured while the patient is apnoeic with the APL valve of the anaesthetic machine set to 35 cm H2O and the fresh gas flow set to 6 L/min
Measured: within 10 minutes of successful device placement
Secondary outcomes (3)
airway stability
the tidal volumes will be measured in different head positions and the leak fractions calculated.
Measured: within 30 minutes of device placement
ease of device placement
the ease of device placement will be evaluated by Visual Analogue Scale
Measured: within 30 minutes of induction of general anesthesia
complications during the anesthetic
complications that may be related to the device use will be monitored including but not limited to desaturation episodes, laryngospasm, loss of airway, need to switch ot alternative device, blood staining on mask removal sore throat, dysphonia, dysphagia
Measured: from the start of device insertion untill discharge from recovery, an expected average of 2 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 startMar 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baska Mask Efficacy and Safety in ChildrenStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Laffey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Laffey, University College Hospital Galway
- Investigators
- Michael Scully, FFARCSI, Principal investigator, UCHG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625078
- Sponsor's protocol ID
- C.A.657
- Status last verified
- May 2014
- First submitted
- 23 Mar 2012
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. 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 in Children
- ClinicalTrials.gov ID
- NCT01625078
- Acronym / sponsor ID
- C.A.657
- Keywords
- Baska Mask, Supraglottic airway device, Children, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- John LaffeyUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (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 wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baska mask | Experimental | Device: Placement and use of Baska mask |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- consent
- BMI 15-35
- weight over 30kg or age 8-16 yrs
- non-urgent surgery of planned duration up to 2 hrs
Key exclusion criteria (4 listed)
- neck pathology
- previous or anticipated problems with the upper GI or upper airway
- increased risk of gastric aspiration
- expected 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 a supraglottic airway during general anesthesia | Device | Baska mask |
Primary outcome
Device insertion success rate
Time frame: within 30 minutes of induction of general anesthesia
device airway leak pressure
Time frame: within 10 minutes of successful device placement
the airway l;eak pressure is defined as the plateau airway pressure measured while the patient is apnoeic with the APL valve of the anaesthetic machine set to 35 cm H2O and the fresh gas flow set to 6 L/min
3 secondary outcomes
airway stability
Time frame: within 30 minutes of device placement
ease of device placement
Time frame: within 30 minutes of induction of general anesthesia
complications during the anesthetic
Time frame: from the start of device insertion untill discharge from recovery, an expected average of 2 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 29 May 2014.
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.
Michael Scully, FFARCSI principal investigator
UCHG
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 Baska Mask Efficacy and Safety in Children, run by John Laffey 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 4 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 29 May 2014. 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 insertion success rate (time frame: within 30 minutes of induction of general anesthesia). 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 29 May 2014.