Performance and Safety of an Airway Management DeviceNCT01753635
Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients
A study testing supraglottic airway placement and use in people with Performance and Safety of an Airway Management Device, run by John Laffey at 1 site in Ireland.
Trial summary
The purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients. The investigators have performed a number of studies on novel airway devices, including 3 studies on the Baska mask. 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
- 150 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2012to Jan 2013
- Phase
- Interventional
- 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) 35 or less
- Age 16-85
- Non-urgent surgery of planned duration under 4 hours
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
- BMI >35
- Predicted or previously documented difficult airway
- Live Pregnancy
- Increased risk for Gastric Aspiration
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients.
The investigators have performed a number of studies on novel airway devices, including 3 studies on the Baska mask. This trial will compare some performance characteristics of the studied devices, including airway seal pressures, insertion success rates, device use difficulty scores. Additional performance and device safety data will be accumulated.
The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask vs LMA.
Read the detailed description
Supraglottic airway devices have established place in the airway management in patients undergoing general anesthesia.
The Baska mask is a new supraglottic airway device. It's features include:
- Non pressurized cuff designed to reduce the risk of oropharyngeal tissue damage.
- Improved cuff seal during the inspiratory phase of positive pressure ventilation
- An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.
- Integrated bite-block to reduce the risk of patients biting and blocking the airway.
This study is randomized, single-blinded, controlled trial. The participants will be allocated to two groups, in which either the Baska mask or the single use LMA will be the primary airway management device.
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.
Standard anesthetic preassesment and anesthesia 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 related to device use and other.
Follow up will be performed.
The investigators have two primary hypotheses:
- That the Baska mask is non-inferior to LMA in respect if first placement attempt success rate. A greater than 15% difference in success rate will be considered a clinically important difference and will disprove this hypothesis.
- The Baska mask is superior in respect of seal pressure. A 20% higher seal pressure with Baska as compared to the LMA device seal pressure will be considered a clinically important difference.
Interim analysis will be performed once 75 patients are recruited per group. This is reasonable as this figure exceeds that required to prove or disprove the primary hypothesis regarding the seal pressure. The study will only be stopped at this stage if the non-inferiority hypothesis is disproven with P value < 0.01
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, single use LMA device, 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
| Study group | Role | What they receive |
|---|---|---|
| Baska mask | Experimental | In this arm the Baska mask will be used as the airway management device Receives: Device: supraglottic airway placement and use |
| single use laryngeal mask airway device (LMA) | Active comparator | in this arm a single use LMA device will be used for airway management. 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 time placement attempt success rate that is no more than 15% less than that of the comparator - a single use LMA device.
Measured: within 30 minutes of commencement of general anesthesia
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 of the Baska mask is 20% higher than that of the comparator single-use LMA device.
Measured: Within 30 minutes of commencement of general anesthesia
Secondary outcomes (7)
Overall rate of successful placement of the supraglottic device
Measured: Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed.
Number of device placement attempts
Measured: Within 30 minutes of commencement of general anesthesia
Number of optimization maneuvers during device placement
Measured: Within 30 minutes of commencement of general anesthesia
user rated Device difficulty score
the investigators will use 10 cm visual analogue scale to score the whole experience of using the device until successful ventilation is achieved.
Measured: within 30 minutes of commencement of general anesthesia
vitals parameter stability
The investigators will record non-invasive arterial oxygen saturation, heart rate and blood pressure preoperatively, after induction of general anesthesia and after placement of the airway device.
Measured: in the period immediately before and within the first 35 minutes of general anesthesia
Laryngeal view obtained on fiberoptic assessment
The investigators will perform this when feasible.
Measured: within 2 hours of commencement of general anesthesia
Complication rates
Complications specifically monitored will be: blood staining, laryngospasm, lip damage, throat pain, dysphagia, dysphonia, heartburn, nausea and vomiting.
The investigators will record other complications related to the use of the device, including but not limited to: desaturation, need to reposition device or switch to alternative device, teeth damage, regurgitation, aspiration
Measured: from the moment general anesthesia commenced up to 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionJan 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 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
- Patrick Neligan, FFARCSI, Principal investigator, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753635
- Sponsor's protocol ID
- C.A.724
- Status last verified
- Mar 2013
- First submitted
- 17 Dec 2012
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients
- ClinicalTrials.gov ID
- NCT01753635
- Acronym / sponsor ID
- C.A.724
- Keywords
- Baska mask, LMA, single use LMA device, laryngeal mask airway, supraglottic airway device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- John LaffeyUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Dec 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 purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients.
The investigators have performed a number of studies on novel airway devices, including 3 studies on the Baska mask. This trial will compare some performance characteristics of the studied devices, including airway seal pressures, insertion success rates, device use difficulty scores. Additional performance and device safety data will be accumulated.
The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask vs LMA.
Detailed description
Supraglottic airway devices have established place in the airway management in patients undergoing general anesthesia.
The Baska mask is a new supraglottic airway device. It's features include:
- Non pressurized cuff designed to reduce the risk of oropharyngeal tissue damage.
- Improved cuff seal during the inspiratory phase of positive pressure ventilation
- An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.
- Integrated bite-block to reduce the risk of patients biting and blocking the airway.
This study is randomized, single-blinded, controlled trial. The participants will be allocated to two groups, in which either the Baska mask or the single use LMA will be the primary airway management device.
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.
Standard anesthetic preassesment and anesthesia 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 related to device use and other.
Follow up will be performed.
The investigators have two primary hypotheses:
- That the Baska mask is non-inferior to LMA in respect if first placement attempt success rate. A greater than 15% difference in success rate will be considered a clinically important difference and will disprove this hypothesis.
- The Baska mask is superior in respect of seal pressure. A 20% higher seal pressure with Baska as compared to the LMA device seal pressure will be considered a clinically important difference.
Interim analysis will be performed once 75 patients are recruited per group. This is reasonable as this figure exceeds that required to prove or disprove the primary hypothesis regarding the seal pressure. The study will only be stopped at this stage if the non-inferiority hypothesis is disproven with P value < 0.01
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 useIn this arm the Baska mask will be used as the airway management device |
| single use laryngeal mask airway device (LMA) | Active comparator | Device: supraglottic airway placement and usein this arm a single use LMA device will be used for airway management. |
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) 35 or less
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
- 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 use | Device | Baska mask, single use laryngeal mask airway device (LMA) |
Primary outcome
Rate of successful placement of the supraglottic device on first attempt
Time frame: within 30 minutes of commencement of general anesthesia
The hypothesis is that the Baska mask will have first time placement attempt success rate that is no more than 15% less than that of the comparator - a single use LMA device.
Seal pressure of the supraglottic device
Time frame: Within 30 minutes of commencement of general anesthesia
The investigators will measure the airway seal provided by the device used. The hypothesis is that the seal pressure of the Baska mask is 20% higher than that of the comparator single-use LMA device.
7 secondary outcomes
Overall rate of successful placement of the supraglottic device
Time frame: Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed.
Number of device placement attempts
Time frame: Within 30 minutes of commencement of general anesthesia
Number of optimization maneuvers during device placement
Time frame: Within 30 minutes of commencement of general anesthesia
user rated Device difficulty score
Time frame: within 30 minutes of commencement of general anesthesia
vitals parameter stability
Time frame: in the period immediately before and within the first 35 minutes of general anesthesia
Laryngeal view obtained on fiberoptic assessment
Time frame: within 2 hours of commencement of general anesthesia
Complication rates
Time frame: from the moment general anesthesia commenced up to 3 days 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 19 Mar 2013.
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.
Patrick Neligan, FFARCSI principal investigator
University College Hospital Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supraglottic airway placement and use in people with Performance and Safety of an Airway Management Device, 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 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 19 Mar 2013. 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.
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 30 minutes of commencement 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 19 Mar 2013.