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N/A N=60 Randomized Double-blind Screening

The Laryngeal Mask Airway in Edentulous Geriatric Patients

Anaesthesia

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: First Attempt's Success Rate of Insertion — 73.3; 86.6 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Group LMA Unique™ (Device); Group LMA Supreme™ (Device)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
Dokuz Eylul University
Primary completion
Apr 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
First Attempt's Success Rate of Insertion
73.3; 86.6
SECONDARY
Oropharyngeal Leak Pressure
17.1; 20.56

Summary

With an aging population a prevalence of edentulous patients increased above 60 % among individuals aged ≥65 yr. Face mask ventilation of these edentulous patients is often difficult because of the inadequate fitting of the standard mask to the face. In addition, because of a reduction in muscle tone under general anesthesia, the air space in the oropharynx is reduced, and posterior displacement of the tongue, soft palate and epiglottis tend to close the airway. The laryngeal mask airway (LMA) provides a better alternative to the standard face mask if the facial contours of the patient are not suited to the standard face mask. It is more difficult to perform bag-mask ventilation in edentulous patients than in patients with intact dentition. The laryngeal mask airway (LMA) provides a better alternative to the standard face mask if the facial contours of the patient are not suited to the standard face mask. We aimed to compare the routinely used laryngeal mask airway in our clinic, the LMA Unique™ with the newly released LMA Supreme™ in edentulous elderly patients for the success in first attempt insertion, ease and time of insertion, and oropharyngeal leak pressure.

Eligibility Criteria

Inclusion Criteria

  • ASA I-III
  • 65 years and older

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02197377). 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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