A New Insertion Technique for Laryngeal Mask Airway

NCT01749033 | Completed Results

• 1 other identifier: STU00046964
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Morbidity

Keywords

Intubation; Airway; Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (4)

• Number of Subjects Who Present With Postoperative Sore Throat

  The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.

  24 hours

• The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia

  The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphonia. Difficulty in speaking as assessed by the study team and reported by the participant 24 hours after LMA airway placement.

  24 hours

• The Primary Outcomes for This Study Will be Postoperative Dysphagia.

  The primary outcomes for this study will be postoperative pharyngolaryngeal complication of dysphagia 24 hours after airway placement. This is assessed by a study team member during the 24 hour follow up or reported by the participant.

  24 hours

• The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.

  The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement.

  24 hours

Secondary Outcomes (2)

• Severity of Sore Throat

  24 hours

• Blood on LMA After Removal

  Immediately after LMA removal

Study Arms (3)

Group 1 classic

ACTIVE COMPARATOR

Group 1 Using the classic inserting technique and completely deflated LMA (Laryngeal Mask Airway)recommended in the LMA manual.

Other: Group 1 Classic

Group 2 pre inflated

ACTIVE COMPARATOR

Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA (Laryngeal Mask Airway) from the manufacturer

Other: Group 2 pre-inflated

Group 3 ELL-PIC technique

ACTIVE COMPARATOR

Group 3 (ELL-PIC): Using the ELL-PIC technique.

Other: Group 3 ELL-PIC

Interventions

Group 1 Classic OTHER

Active Comparator: Group 1 classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.

Group 1 classic

Group 2 pre-inflated OTHER

Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA (Laryngeal Mask Airway) from the manufacturer.

Group 2 pre inflated

Group 3 ELL-PIC OTHER

Group 3 (ELL-PIC): Using the ELL-PIC technique

Group 3 ELL-PIC technique

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Hu LQ, Leavitt OS, Malwitz C, Kim H, Doty RA Jr, McCarthy RJ. Comparison of laryngeal mask airway insertion methods, including the external larynx lift with pre-inflated cuff, on postoperative pharyngolaryngeal complications: A randomised clinical trial. Eur J Anaesthesiol. 2017 Jul;34(7):448-455. doi: 10.1097/EJA.0000000000000650.

  PMID: 28590309 DERIVED

Limitations and Caveats

We did not limit the intracuff pressure of the device, but rather used the manufactures recommended volume in the cuff. . There are no current standard of care guidelines for the ideal intracuff pressures within the oropharngolaryngeal mask airway.

Results Point of Contact

• Title: Ling Hu M.D.
• Organization: Northwerstern University

l-hu2@northwestern.edu

312-695-3428

Study Officials

• David Walega, MD

  Northwestern University

  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: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 13, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 17, 2019
• Results First Posted: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)