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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baska mask | Experimental | In this arm the Baska mask will be used as the airway management device |
|
| single use laryngeal mask airway device (LMA) | Active Comparator | in this arm a single use LMA device will be used for airway management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| supraglottic airway placement and use | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Within 30 minutes of commencement of general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Overall rate of successful placement of the supraglottic device | Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed. | |
| Number of device placement attempts | Within 30 minutes of commencement of general anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Neligan, FFARCSI | Galway University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galway University Hospitals | Galway | Ireland |
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| Number of optimization maneuvers during device placement | 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. | 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. | 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. | 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 | from the moment general anesthesia commenced up to 3 days postoperatively |