Performance and Safety of an Airway Management DevicePhase 2NCT01482650
Comparison of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients
A Phase 2 study testing supraglottic airway placement and use in people with Performance and Safety of an Airway Management Device, run by University College Hospital Galway at 1 site in Ireland.
Trial summary
The investigators have 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 proposed study the investigators would like to compare directly,in a randomized clinical trial, this device with the device the… Read more about this study
- Who is it for?
- Ages 16 to 85 years, women only
- Conditions the study is for
- Performance and Safety of an Airway Management Device
- What is being tested?
- supraglottic airway placement and use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2011to Feb 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female
- 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
- Live Pregnancy
- Increased risk for Gastric Aspiration
- Current participation in another Clinical Study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients
The investigators have 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 proposed study the investigators would like to compare directly,in a randomized clinical trial, this device with the device the investigators routinely use - the single use laryngeal mask airway - LMA, in female patients undergoing general anaesthesia.
This study will determine which device performs best, as measured by key parameters (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc) as regarding the performance and safety profile of the Baska mask and the LMA.
Read more
The investigators have two study hypotheses, namely (1) non-inferiority of first placement attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs LMA.
A number of secondary endpoints will be monitored and analyzed (time to and ease of insertion, failure rate, complications etc).
Read the detailed description
Airway management is essential component of the safe and efficient provision of general anaesthesia. Supraglottic airway devices have established place in the airway management.
The Baska mask is a new supraglottic airway device. It bears many of the features of the industry standard - the laryngeal mask airway (LMA), with few potential improvements:
- The cuff is not pressurized thus reducing the risk of oropharyngeal tissue damage.
- Improved cuff seal during the inspiratory phase of positive pressure ventilation which may reduce leak and make ventilation more efficient.
- An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.
- The Baska mask is inserted in neutral head position thus reducing the need for neck manipulation.
- There is integrated bite-block to reduce the risk of patients biting and blocking the airway.
The results from the observational study of the performance of the Baska mask are promising and the investigators feel a randomized comparative study against the gold standard device, the Laryngeal Mask Airway (LMA) is justified.
This study is a randomized, single blinded, controlled clinical trial. The participants will be allocated to two groups, in which the investigators will use either a single use LMA device or the Baska mask (single use).
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent and screened for inclusion and exclusion criteria.
Standard anaesthetic preassessment and anaesthesia will be provided.
Consenting patients will be randomly allocated to either of the 2 study groups.
Protocol for airway size selection and attempts at placement will be followed.
The investigators will monitor a number of parameters, including time and ease of insertion, airway seal pressure, airway leak, complications, haemodynamic and ventilatory parameters, ease of removal and other.
Follow up will be performed.
The investigators have two primary hypotheses:
- That the BASKA mask will have an insertion success rate that is no more than 20% less than that of the single use LMA device.
- That the seal pressure with the BASKA mask will be 40% higher than that of the single use LMA.
In addition to the above the investigators will evaluate a number of secondary outcomes.
- Being tested
- supraglottic airway placement and use
- Keywords
- Baska mask, LMA, laryngeal mask airway, supraglottic airway device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraglottic airway placement and useDevice
The investigators will place the device (Baska mask or LMA) according to a pre-defined protocol and monitor its performance intra and postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Baska mask | Experimental | Not described Receives: Device: supraglottic airway placement and use |
| single use laryngeal mask airway (LMA) | Active comparator | Not described Receives: Device: supraglottic airway placement and use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful placement of the supraglottic device on first attempt
The hypothesis is that the BASKA mask will have first placement attempt success rate that is no more than 20% less than that of the single use LMA device.
Measured: Within 30minutes of commencement of general anaesthesia
Seal pressure of the supraglottic device
The investigators will measure the airway seal provided by the device used. The hypothesis is that the seal pressure with the BASKA mask will be 40% higher than that of the single use LMA.
Measured: Within 30minutes of commencement of general anaesthesia, immediately after successful placement is accomplished.
Secondary outcomes (8)
Overall rate of successful placement of the supraglottic device
Measured: Within 30minutes of commencement of general anaesthesia. Up to 3 device placement attempts are allowed.
Number of device placement attempts
Measured: Within 30minutes of commencement of general anaesthesia
User - rated Ease of insertion of the device
the investigators will use 10cm visual analogue scale
Measured: Within 30minutes of commencement of general anaesthesia
vital parameters stability
The investigators will record noninvasive arterial oxygen saturation, heart rate and blood pressure preoperatively, after anaesthesia is induced and after the airway is placed.
Measured: In the period immediately before and during the first 35 minutes of the general anaesthesia
Laryngeal view obtained on fiberoptic assessment
The investigators will perform this where feasible.
Measured: within 2hours of commencement of general anaesthesia
User rated Ease of removal of the device
The investigators will use 10cm visual analogue scale
Measured: At the time of device removal (usually within 15 minutes before or after the end of the general anaesthesia)
Complication rates
Complications specifically monitored will be: blood staining, laryngospasm, lip damage, pain, dysphagia, dysphonia.
The investigators will record other complications related to the use of the device, including but not limited to: desaturation episodes, loss of airway with need to manipulate mask/switch to alternative device, teeth damage, regurgitation, aspiration
Measured: from the moment general anaesthesia commenced up to 3 days postoperatively
Duration of successful insertion attepts
This outcome measure is defined as the period from the time device touched until successfull ventilation is achieved as per protocol.
Measured: Within 30 minutes of commencement of general anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 an Airway Management 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 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 Laffey, FFARCSI, Principal investigator, National University of Ireland, Galway, and Galway University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482650
- Sponsor's protocol ID
- C.A. 650
- Status last verified
- Jun 2012
- First submitted
- 25 Nov 2011
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients
- ClinicalTrials.gov ID
- NCT01482650
- Acronym / sponsor ID
- C.A. 650
- Keywords
- Baska mask, LMA, laryngeal mask airway, supraglottic airway device
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Nov 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 investigators have 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 proposed study the investigators would like to compare directly,in a randomized clinical trial, this device with the device the investigators routinely use - the single use laryngeal mask airway - LMA, in female patients undergoing general anaesthesia.
This study will determine which device performs best, as measured by key parameters (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc) as regarding the performance and safety profile of the Baska mask and the LMA.
The investigators have two study hypotheses, namely (1) non-inferiority of first placement attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs LMA.
A number of secondary endpoints will be monitored and analyzed (time to and ease of insertion, failure rate, complications etc).
Detailed description
Airway management is essential component of the safe and efficient provision of general anaesthesia. Supraglottic airway devices have established place in the airway management.
The Baska mask is a new supraglottic airway device. It bears many of the features of the industry standard - the laryngeal mask airway (LMA), with few potential improvements:
- The cuff is not pressurized thus reducing the risk of oropharyngeal tissue damage.
- Improved cuff seal during the inspiratory phase of positive pressure ventilation which may reduce leak and make ventilation more efficient.
- An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.
- The Baska mask is inserted in neutral head position thus reducing the need for neck manipulation.
- There is integrated bite-block to reduce the risk of patients biting and blocking the airway.
The results from the observational study of the performance of the Baska mask are promising and the investigators feel a randomized comparative study against the gold standard device, the Laryngeal Mask Airway (LMA) is justified.
This study is a randomized, single blinded, controlled clinical trial. The participants will be allocated to two groups, in which the investigators will use either a single use LMA device or the Baska mask (single use).
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent and screened for inclusion and exclusion criteria.
Standard anaesthetic preassessment and anaesthesia will be provided.
Consenting patients will be randomly allocated to either of the 2 study groups.
Protocol for airway size selection and attempts at placement will be followed.
The investigators will monitor a number of parameters, including time and ease of insertion, airway seal pressure, airway leak, complications, haemodynamic and ventilatory parameters, ease of removal and other.
Follow up will be performed.
The investigators have two primary hypotheses:
- That the BASKA mask will have an insertion success rate that is no more than 20% less than that of the single use LMA device.
- That the seal pressure with the BASKA mask will be 40% higher than that of the single use LMA.
In addition to the above the investigators will evaluate a number of secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baska mask | Experimental | Device: supraglottic airway placement and use |
| single use laryngeal mask airway (LMA) | Active comparator | Device: supraglottic airway placement and use |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Written informed consent
- ASA 1-3
- No relevant allergies
- Body-mass index (BMI) 20-35
Key exclusion criteria (8 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 |
|---|---|---|
| supraglottic airway placement and useThe investigators will place the device (Baska mask or LMA) according to a pre-defined protocol and monitor its performance intra and postoperatively. | Device | Baska mask, single use laryngeal mask airway (LMA) |
Primary outcome
Rate of successful placement of the supraglottic device on first attempt
Time frame: Within 30minutes of commencement of general anaesthesia
The hypothesis is that the BASKA mask will have first placement attempt success rate that is no more than 20% less than that of the single use LMA device.
Seal pressure of the supraglottic device
Time frame: Within 30minutes of commencement of general anaesthesia, immediately after successful placement is accomplished.
The investigators will measure the airway seal provided by the device used. The hypothesis is that the seal pressure with the BASKA mask will be 40% higher than that of the single use LMA.
8 secondary outcomes
Overall rate of successful placement of the supraglottic device
Time frame: Within 30minutes of commencement of general anaesthesia. Up to 3 device placement attempts are allowed.
Number of device placement attempts
Time frame: Within 30minutes of commencement of general anaesthesia
User - rated Ease of insertion of the device
Time frame: Within 30minutes of commencement of general anaesthesia
vital parameters stability
Time frame: In the period immediately before and during the first 35 minutes of the general anaesthesia
Laryngeal view obtained on fiberoptic assessment
Time frame: within 2hours of commencement of general anaesthesia
User rated Ease of removal of the device
Time frame: At the time of device removal (usually within 15 minutes before or after the end of the general anaesthesia)
Complication rates
Time frame: from the moment general anaesthesia commenced up to 3 days postoperatively
Duration of successful insertion attepts
Time frame: Within 30 minutes of commencement of general anaesthesia
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 19 Jun 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 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 supraglottic airway placement and use in people with Performance and Safety of an Airway Management 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 7 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 19 Jun 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?
Rate of successful placement of the supraglottic device on first attempt (time frame: Within 30minutes of commencement of general anaesthesia). 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 19 Jun 2012.