At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Randomized Trial Comparing the Performance of Two Supraglottic Airway Management Devices: I-Gel and Supreme LMA
In Brief
A clinical study evaluating I-Gel supraglottic airway device, LMA Supreme supraglottic airway device, and 1 other intervention for Anesthesia Airway Management. Completed, enrolled 100 participants across 1 site.
Detailed Summary
This study will compare two supraglottic airway devices currently on the market. Supraglottic airway devices are used during general anesthesia to provide a patent airway. They are inserted blindly into the mouth once the patient has lost consciousness and they cover the laryngeal inlet. The I-Gel and the Supreme laryngeal mask airway (LMA) are the two devices to be compared. The I-Gel has no inflatable cuff, which makes it different from all other supraglottic airway devices currently in use. The Supreme shares some characteristics of the other LMA devices, but it is disposable. Our main goal will be to compare the airway leak pressure and the peak airway pressure of each devices. We will also measure the time needed for insertion, number of attempts needed to secure the airway and side effects related to the airway (cough, dysphagia, trauma, hoarseness of voice, sore throat).
Study Details
Timeline
Interventions
2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA.
In the LMA Supreme group, the same interventions will be done as in the I-Gel group. The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Leak pressure will also be measure at 45 mL. Once the leak test is done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
In case both supraglottic airway devices fail, a standard endotracheal tube will be inserted