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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
Sponsor:
Information provided by (Responsible Party):
Sule Ozbilgin, Dokuz Eylul University

Brief 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.


Condition or disease Intervention/treatment Phase
Anaesthesia Device: Group U (UNIQUE) Device: I-GEL Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
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

Arm Intervention/treatment
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.
Other Names:
  • Laryngeal Mask Airway-Unique
  • Teleflex, The Laryngeal Mask Company Limited, Singapore .

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
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

Other Name: Group I (I-GEL): I-GEL




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Number of Attempts [ Time Frame: Baseline to first successful ventilation, ]
    The number of attempts until succesful placement of airway device

  3. Ease of Placement [ Time Frame: Baseline ]

    Ease of placement:

    1. no reaction
    2. straining, retching

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II
  • 18-65 years

Exclusion Criteria:

  • Any neck or upper respiratory pathology
  • Those at risk of gastric content regurgitation/aspiration (previous upper gastro-intestina system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)
  • Possibility of and those with history of difficult intubation (history of impossible intubation, Mallampati classification 3-4, sterno mental distance less than 12 cm, thyromental distance less than 6 cm, head extension less than 90 degrees, mouth opening less than 1.5 cm)
  • Those with low pulmonary compliance or high airway resistance (morbid obesity, lung disease)
  • Throat pain, dysphagia and dysphonia
  • Patients with cervical disc hernia

Information from the National Library of Medicine

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


Locations
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Turkey
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
Izmi̇r, Narlıdere, Turkey, 35320
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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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
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Responsible Party: Sule Ozbilgin, Anaesthesiology and Reanimation, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT02163486    
Other Study ID Numbers: 10-11.1/30
First Posted: June 13, 2014    Key Record Dates
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018
Last Verified: December 2017
Keywords provided by Sule Ozbilgin, Dokuz Eylul University:
I-gel
oropharyngeal leak pressure
head position