A New Insertion Technique for Laryngeal Mask Airway

NCT ID: NCT01749033

Last Updated: 2019-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-12-31

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.

Detailed Description

The LMA will be inserted based on one of three methods randomly assigned to each patient. The ELLIA technique involves gently lifting the patient's laryngeal structures (throat) while placing the LMA to oppose the force of gravity. Whereas the traditional method of placement involves guiding the LMA through the pharynx with a finger inserted into the pharynx, the ELLIA method avoids this step. General anesthesia will be maintained at the discretion of the Anesthesiologist throughout the surgical procedure. At the end of the case, as would normally occur, the LMA will be removed from the patient's airway and the patient will be taken to the PACU, where he or she will be cared for as usual. At one and two hours postoperatively, blinded research assistants will assess the patient for sore throat, hoarse voice, and difficulty swallowing. Finally, at 24 hours the patient will receive a telephone call from a blinded research assistant assessing for the same outcomes. These data will be collected and presented.

Conditions

Airway Morbidity

Keywords

Intubation; Airway; Laryngeal Mask Airway

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group 1 classic

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

Group Type: ACTIVE_COMPARATOR

Group 1 Classic

Intervention Type: OTHER

Active Comparator: Group 1 classic

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

Group 2 pre inflated

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 Type: ACTIVE_COMPARATOR

Group 2 pre-inflated

Intervention Type: 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 3 ELL-PIC technique

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

Group Type: ACTIVE_COMPARATOR

Group 3 ELL-PIC

Intervention Type: OTHER

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

Interventions

Group 1 Classic

Active Comparator: Group 1 classic

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

Intervention Type: OTHER

Group 2 pre-inflated

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.

Intervention Type: OTHER

Group 3 ELL-PIC

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David Walega

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Walega, MD

Role: STUDY_DIRECTOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28590309 (View on PubMed)

Other Identifiers

STU00046964

Identifier Type: -

Identifier Source: org_study_id