90° Rotation Technique for LMA FlexibleTM Insertion

Not Applicable

Completed

• Conditions: Laryngeal Masks
• Interventions: Procedure: 90° rotational technique

• Registration Number: NCT03028896
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2015-04-02
• Primary Completion: 2016-03-04
• Study Completion: 2017-01-19
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Results First Submitted: 2018-01-26
• Results First Submitted QC: 2018-01-26
• Results First Posted: 2018-09-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rotational	90° rotational technique	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.

Primary Outcome Measures

Name	Time	Method
First Attempt Success Rate	at induction	the first attempt success rate of insertion of LMA FlexibleTM

Secondary Outcome Measures

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