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N/A N=103 Randomized Double-blind Screening

Comparison Between the I-gel and the LMA-Unique

Anaesthesia

Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Oropharyngeal Leak Pressure — 25.06; 28.24; 22.88; 26.62 cm H20

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Group U (UNIQUE) (Device); I-GEL (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Dokuz Eylul University
Primary completion
Feb 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Oropharyngeal Leak Pressure
25.06; 28.24; 22.88; 26.62; 27.30; 26.04
SECONDARY
The Time for Successful Placement (Second)
13.46; 12.14
SECONDARY
Number of Attempts
48; 48; 2; 1; 0; 1
SECONDARY
Ease of Placement
49; 49; 1; 1
SECONDARY
Incidence of Post-operative Sore Throat
5; 0

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02163486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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