CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 103 enrolled
Drug / intervention
Group U (UNIQUE) +1 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02163486
NCT02163486N/ACompleted

The Influence of Head and Neck Position On The Oropharyngeal Leak Pressure of LMA Unique ™ and I-GEL™

Dokuz Eylul University·interventional·Posted Jun 13, 2014·Updated Oct 19, 2018

In Brief

A clinical study evaluating Group U (UNIQUE) and I-GEL for Anaesthesia. Completed, enrolled 103 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaesthesia
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2014
Enrollment StartDec 1, 2010
Primary CompletionFeb 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.1 years ago

Interventions

Group U (UNIQUE)device

Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.

I-GELdevice

Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff. I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc