NCT03542890

Respiration and The Airway With Laryngeal Masks

Completed Last updated 17 September 2021

What this trial tests

trial testing Baska Mask in Supraglottic Airway Devices in 140 participants. Completed in 10 August 2021.

Timeline

14 June 2018

Primary endpoint
8 July 2021

10 August 2021

Quick facts

Lead sponsor	Reham Ali Abdelhaleem Abdelrahman
Status	Completed
Study type	OBSERVATIONAL
Enrollment	140
Start date	14 June 2018
Primary completion	8 July 2021
Estimated completion	10 August 2021
Sites	1 location across Egypt

Drugs / interventions tested

• Baska Mask
• I-gel

Conditions studied

• Supraglottic Airway Devices — all drugs for Supraglottic Airway Devices →

Sponsor

Reham Ali Abdelhaleem Abdelrahman

Who can join

Adults 18 to 45, female only, with Supraglottic Airway Devices. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Baska® mask (Proact Medical Systems, Frenchs Forest NSW, Australia) is displayed in figure 1 which is the latest addition to an array of supra-glottic airway devices in clinical use. It has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway, potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff over inflation, a known complication with other supraglottic airways. However, the cuff differs from other non-inflatable cuffs in that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation ,the cuff itself is inflated which may improve the seal so reducing leak and make ventilation more efficient. The Baska mask has two ports (one for venting and other for gastric tube insertion ), so it incorporates an inlet that fits into the upper oesophagus and the dorsal surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and towards the side channels to which suction can be attached to facilitate aspiration of this space. These features may reduce the risk of pulmonary aspiration of secretions or gastric contents that accumulate in the supraglottic area. In addition, there is integrated bite-block, which reduces the risk of patients biting and blocking the airway. There is insertion tab which is an extended hand-tab attached to the cuff that permits the operator to control the degree of flexion of the device during the insertion. The Baska® mask is inserted in the neutral head position, which may reduce the need for neck manipulation. Initial experience with Baska®mask has demonstrated it to be a suitable airway device for procedures less than 2 hours or when endotracheal intubation is not required.

I-gel airway (Intersurgical Ltd, Workingham, Berkshire,United Kingdom) is displayed in figure 2 which is second generation supraglottic airway devices (SADs) that was introduced in 2007. The I-gel is a single use (SADs) composed of a soft ,gel-like, non-inflatable cuff made from a thermoplastic elastomer. It has a widened , flattened stem with a rigid bite block that acts as a buccal stabilizer to reduce axial rotation and mal-positioning and a port for gastric tube insertion. It is a latex free device that does not require digital insertion into mouth of patient. With an epiglottic rest and wider and shorter stem, the I-gel gives an optimal view of the glottis with a fiber- optic scope so a shorter tube is ideal for endotracheal tube placement. Moreover, I-gel can be inserted as fast as classic LMA (Laryngeal Mask Airway) with adequate ventilation in patients and has no major airway complications. Therefore, it could be a good alternative to classic LMA in emergency airway management or general anesthesia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.