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Clinical Trial Summary

The study compares the LMA Supreme™ versus the Spritztube® tracheal cannula in anesthetized adult patients.

The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula.

In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed.

The investigators hypothesize that the LMA Supreme™ versus the Spritztube® tracheal cannula will similarly perform during anesthetized adult patients despite differences in their structural design.


Clinical Trial Description

A new extraglottic airway device, the Spritztube® [tracheal cannula, Med Europe s.r.l], was developed combining the ability to perform both EAD ventilation and oro-tracheal fibreoptic intubation using the same device. The Spritztube® consists of a silicone cannula with two low-pressure cuffs: a proximal cuff, designed to seal the pharynx cranially of the epiglottis and a distal cuff, designed to seal the oesophagus. The positioning of this device requires the aid of a spindle, that keep the cuffs on the same line and it is rigid enough to allow the passage through oropharynx tissue. That can be inserted blindly as extraglottic device or through the use of direct laryngoscopy or fibroscopy as tracheal cannula.

The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula.

In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03443219
Study type Interventional
Source St. Bortolo Hospital
Contact
Status Completed
Phase N/A
Start date September 15, 2016
Completion date October 20, 2017

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