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N/A N=450 Randomized Double-blind Other

A New Insertion Technique for Laryngeal Mask Airway

Airway Morbidity

Enrolled (actual)
450
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Number of Subjects Who Present With Postoperative Sore Throat — 71; 71; 67 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Group 1 Classic (Other); Group 2 pre-inflated (Other); Group 3 ELL-PIC (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Northwestern University
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects Who Present With Postoperative Sore Throat
71; 71; 67
PRIMARY
The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia
39; 31; 25
PRIMARY
The Primary Outcomes for This Study Will be Postoperative Dysphagia.
45; 38; 34
PRIMARY
The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.
83; 80; 78 .76
SECONDARY
Severity of Sore Throat
143; 143; 102
SECONDARY
Blood on LMA After Removal
26; 24; 13 .05

Summary

A laryngeal mask airway ("LMA") is an airway device that is commonly used and placed under general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is similar to an "endotracheal tube" (a breathing tube) but is less invasive. It is also placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous studies have examined several variables that may affect how often complications occur; these variables include giving anti-inflammatory medications and inflating the LMA to different pressures (the "working" end of the LMA, which rests in the patient's throat, has a cuff that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3 placement techniques - the traditional placement technique, a slightly different traditional placement technique, and a new technique, abbreviated the "ELLIA" method. The hypothesis of this study is that a new LMA insertion technique will have no difference in postoperative pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.

Eligibility Criteria

Inclusion Criteria

  • ASA (American Society of Anesthesiologists patient fitness category) I, II, III
  • Age 18-90
  • General anesthetic for where LMA (Laryngeal Mask Airway) placement is not contraindicated will be included

Exclusion Criteria

  • Small mouth opening
  • Preoperative sore throat/dysphagia/dysphonia
  • Patients at increased risk for aspiration
  • Morbid obesity BMI > 40
  • Untreated chronic GERD
  • Pregnancy
  • Suspected supraglottic abnormalities
  • N2O use
  • Need for oral-pharyngeal suctioning
  • Undergoing oral and nasal surgery
  • Intubation or any oral instrumental manipulations other than
  • LMA placements intraoperatively or postoperatively
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01749033). 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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