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Comparison Between the I-gel and the LMA-Unique

NCT02163486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2018-10-19

Study results available
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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.

Conditions

  • Anaesthesia

Interventions

DEVICE

Group U (UNIQUE)

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.

DEVICE

I-GEL

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

Sponsors & Collaborators

  • Dokuz Eylul University

    lead OTHER

Principal Investigators

  • FARUK ÖZATA, M.D. · STUDY DESİGN

  • BAHAR KUVAKİ, M.D. · Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-02-28
Completion
2011-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02163486 on ClinicalTrials.gov