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NCT02163486Completed

Comparison Between the I-gel and the LMA-Unique

The Influence of Head and Neck Position On The Oropharyngeal Leak Pressure of LMA Unique ™ and I-GEL™
Dokuz Eylul UniversityClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
Anaesthesia
Drug/Device/Intervention
Group U (UNIQUE)
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Dokuz Eylul University
Location
Izmi̇r, Turkey
Timeline & enrollment
Phase
N/A
Start date
Dec 01, 2010
End date
Mar 01, 2011
Enrollment
103 participants
Primary outcome

Oropharyngeal Leak Pressure

Summary

Airway management is one of the basic topics in anesthetic practice. Use of endotracheal
 intubation and face mask are standard methods to maintain an open airway widely adopted for
 many years. As a result of a search for more appropriate choices from the point of view of
 effectiveness, reliability and side effects, supraglottic airway devices (SGAD) have been
 developed.
 
 SGAD's are used for thyroid surgery, ear surgery, carotid endarterectomy, adenotonsillectomy
 and laser pharyngoplasty, which require a variety of head-neck positions. Changing the head
 and neck position leads to changes in the shape of the pharynx, which causes variation in the
 cuff pressure and oropharyngeal leak pressure. Oropharyngeal leak pressure values play a
 determining role in protecting the airway from high cuff pressure. Additionally it shows that
 the laryngeal mask is correctly placed and is a sign of the effectiveness of positive
 pressure ventilation. During surgery head-neck and trunk position may change. As a result
 there is a need for research evaluating the effect of head and neck position on oropharyngeal
 leak pressure during SGAD use.
 
 AIM
 
 The aim of this study is to compare the effect of different head and neck positions on the
 oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Additionally the placement
 duration, ease and success of these two supraglottic airway devices will be compared.

ICD-10 classifications
Anaesthetic, unspecifiedOther and unspecified general anaestheticsOther complications of anaesthesiaLocal anaestheticsAnaesthesia of skin
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT02163486
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT02163486 through Pure Global AI's free database. This phase not specified trial is sponsored by Dokuz Eylul University and is currently Completed. The study focuses on Anaesthesia. Target enrollment is 103 participants.

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