Comparison Between the I-gel and the LMA-Unique

NCT02163486 | Completed Results

• 1 other identifier: 10-11.1/30
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaesthesia

Keywords

I-gel; oropharyngeal leak pressure; head position

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal Leak Pressure

  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.

  Immediately after head and neck positioning is completed

Secondary Outcomes (4)

• The Time for Successful Placement (Second)

  Baseline to first successful ventilation, in seconds

• Number of Attempts

  Baseline to first successful ventilation,

• Ease of Placement

  Baseline

• Incidence of Post-operative Sore Throat

  at postoperative 1st and 24th hours

Study Arms (2)

Group U (UNIQUE)

ACTIVE COMPARATOR

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)

Group I (I-GEL ): Group I-GEL

EXPERIMENTAL

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

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.

Also known as: Laryngeal Mask Airway-Unique, Teleflex, The Laryngeal Mask Company Limited, Singapore .

Group U (UNIQUE)

I-GEL DEVICE

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

Also known as: Group I (I-GEL): I-GEL

Group I (I-GEL ): Group I-GEL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II
• years

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Izmir, Narlıdere, 35320, Turkey (Türkiye)

Location

Results Point of Contact

• Title: Bahar Kuvaki
• Organization: DorkuzEU

ozbilginsule@gmail.com

902324122836

Study Officials

• FARUK ÖZATA, M.D.

  STUDY DESİGN

  PRINCIPAL INVESTIGATOR

• BAHAR KUVAKİ, M.D.

  Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiology and Reanimation

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 13, 2014
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2017-12

Locations

TU (1)