90° Rotation Technique for LMA FlexibleTM Insertion

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Laryngeal Masks

Intervention / Treatment
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* Procedure: 90° rotational technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard<br>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<br>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<br>* the LMA FlexibleTM was rotated counter-clockwise through 90°<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LMA Flexible