90° Rotation Technique for LMA FlexibleTM Insertion

Comparison of Standard Versus 90° Rotation Technique for LMA FlexibleTM Insertion

The 90° rotation technique is known to improve the success rate of conventional LMA but its effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could increase the first attempt success rate of the insertion of LMA FlexibleTM compared to standard technique.

Study Overview

• Status: Completed
• Conditions: Laryngeal Masks
• Intervention / Treatment: Procedure: 90° rotational technique

Detailed Description

One hundred and sixteen adult patients undergoing breast surgery were randomized to the two insertion techniques. The ease of insertion was assessed by the success rate at the first attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after insertion. Postoperative complications were checked.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• American Society of Anesthesiologists class I - II
• Scheduled for elective breast surgery under general anaesthesia using LMA FlexibleTM

Exclusion Criteria:

• known difficult airway
• mouth opening less than 2.5 cm
• limited extension of neck
• recent sore throat
• gastroesophageal reflux disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard; In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.
Experimental: rotational; After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.	Procedure: 90° rotational technique; the LMA FlexibleTM was rotated counter-clockwise through 90°

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Attempt Success Rate	the first attempt success rate of insertion of LMA FlexibleTM	at induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion Time	time from passed mouth of the device to the effective ventilation after inflation of the cuff	at induction
Oropharyngeal Leak Pressure	audible leak during manual ventilation at mouth	at induction
Number of Participants With Blood Staining on the Laryngeal Mask Airway	Number of Participants with blood staining on the laryngeal mask airway.	post op 1min

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Koo BW, Oh AY, Hwang JW, Na HS, Min SW. Comparison of standard versus 90 degrees rotation technique for LMA Flexible insertion: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 7;19(1):95. doi: 10.1186/s12871-019-0773-z.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2015
• Primary Completion (Actual): March 4, 2016
• Study Completion (Actual): January 19, 2017

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: LMA Flexible
• Other Study ID Numbers: SNU-LMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No