A Phase 2 interventional study of supraglottic airway placement and use in Performance and Safety of an Airway Management Device, sponsored by University College Hospital Galway. Completed at 1 site in Ireland. Open to female participants aged 16 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-06-19.
Sponsored by University College Hospital Galway · Phase 2, Interventional, and Treatment
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).
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 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:
In addition to the above the investigators will evaluate a number of secondary outcomes.
University College Hospital Galway is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: supraglottic airway placement and use
Device: supraglottic airway placement and use
The investigators will place the device (Baska mask or LMA) according to a pre-defined protocol and monitor its performance intra and postoperatively.
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.
Time frame: 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.
Time frame: Within 30minutes of commencement of general anaesthesia, immediately after successful placement is accomplished.
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
the investigators will use 10cm visual analogue scale
Time frame: 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.
Time frame: 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.
Time frame: within 2hours of commencement of general anaesthesia
User rated Ease of removal of the device
The investigators will use 10cm visual analogue scale
Time frame: 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
Time frame: 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.
Time frame: Within 30 minutes of commencement of general anaesthesia
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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University College Hospital Galway