Comparison Between the I-gel and the LMA-Unique
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|ClinicalTrials.gov Identifier: NCT02163486|
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Anaesthesia||Device: Group U (UNIQUE) Device: I-GEL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||The Influence of Head and Neck Position On The Oropharyngeal Leak Pressure of LMA Unique ™ and I-GEL™|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||March 2011|
Active Comparator: Group U (UNIQUE)
Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.
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.
Experimental: Group I (I-GEL ): Group I-GEL
Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For > 90 kg no.5. 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
Other Name: Group I (I-GEL): I-GEL
- Oropharyngeal Leak Pressure [ Time Frame: Immediately after head and neck positioning is completed ]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. Head and neck positions are limited to neutral, extension and right laterally deviated.
- The Time for Successful Placement (Second) [ Time Frame: Baseline to first successful ventilation, in seconds ]Duration from mouth opening to first successful ventilation, in seconds
- Number of Attempts [ Time Frame: Baseline to first successful ventilation, ]The number of attempts until succesful placement of airway device
- Ease of Placement [ Time Frame: Baseline ]
Ease of placement:
- no reaction
- straining, retching
- Incidence of Post-operative Sore Throat [ Time Frame: at postoperative 1st and 24th hours ]Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, voice loss and difficulty swallowing , at postoperative 1st and 24th hours.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163486
|Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation|
|Izmi̇r, Narlıdere, Turkey, 35320|
|Principal Investigator:||FARUK ÖZATA, M.D.||STUDY DESİGN|
|Study Director:||BAHAR KUVAKİ, M.D.||Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation|