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90° Rotation Technique for LMA FlexibleTM Insertion

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ClinicalTrials.gov Identifier: NCT03028896
Recruitment Status : Completed
First Posted : January 23, 2017
Results First Posted : September 26, 2018
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
BON WOOK KOO, Seoul National University Bundang Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Laryngeal Masks Procedure: 90° rotational technique Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Standard Versus 90° Rotation Technique for LMA FlexibleTM Insertion
Actual Study Start Date : April 2, 2015
Actual Primary Completion Date : March 4, 2016
Actual Study Completion Date : January 19, 2017
Arms and Interventions
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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°


Outcome Measures
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Primary Outcome Measures :
  1. First Attempt Success Rate [ Time Frame: at induction ]
    the first attempt success rate of insertion of LMA FlexibleTM


Secondary Outcome Measures :
  1. Insertion Time [ Time Frame: at induction ]
    time from passed mouth of the device to the effective ventilation after inflation of the cuff

  2. Oropharyngeal Leak Pressure [ Time Frame: at induction ]
    audible leak during manual ventilation at mouth

  3. Number of Participants With Blood Staining on the Laryngeal Mask Airway [ Time Frame: post op 1min ]
    Number of Participants with blood staining on the laryngeal mask airway.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast surgery
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications of Results:

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Responsible Party: BON WOOK KOO, associator professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03028896    
Other Study ID Numbers: SNU-LMA
First Posted: January 23, 2017    Key Record Dates
Results First Posted: September 26, 2018
Last Update Posted: February 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BON WOOK KOO, Seoul National University Bundang Hospital:
LMA Flexible