90° Rotation Technique for LMA FlexibleTM Insertion
Comparison of Standard Versus 90° Rotation Technique for LMA FlexibleTM Insertion
1 other identifier
interventional
132
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2016
CompletedFirst Submitted
Initial submission to the registry
January 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2017
CompletedResults Posted
Study results publicly available
September 26, 2018
CompletedFebruary 9, 2022
February 1, 2022
11 months
January 19, 2017
January 26, 2018
February 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
First Attempt Success Rate
the first attempt success rate of insertion of LMA FlexibleTM
at induction
Secondary Outcomes (3)
Insertion Time
at induction
Oropharyngeal Leak Pressure
at induction
Number of Participants With Blood Staining on the Laryngeal Mask Airway
post op 1min
Study Arms (2)
standard
NO INTERVENTIONIn 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.
rotational
EXPERIMENTALAfter 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.
Interventions
the LMA FlexibleTM was rotated counter-clockwise through 90°
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists class I - II
- Scheduled for elective breast surgery under general anaesthesia using LMA FlexibleTM
You may not qualify if:
- known difficult airway
- mouth opening less than 2.5 cm
- limited extension of neck
- recent sore throat
- gastroesophageal reflux disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31170926RESULT
Results Point of Contact
- Title
- Dr. Bon-wook Koo
- Organization
- SNUBH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associator professor
Study Record Dates
First Submitted
January 19, 2017
First Posted
January 23, 2017
Study Start
April 2, 2015
Primary Completion
March 4, 2016
Study Completion
January 19, 2017
Last Updated
February 9, 2022
Results First Posted
September 26, 2018
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share