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NCT03028896 Clinical Trial

90° Rotation Technique for LMA FlexibleTM Insertion

Laryngeal Masks Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03028896
Other study ID # SNU-LMA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2, 2015
Est. completion date January 19, 2017

Study information
Verified date February 2022
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date January 19, 2017
Est. primary completion date March 4, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• 90° rotational technique
the LMA FlexibleTM was rotated counter-clockwise through 90°

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

References & Publications (1)

Koo BW, Oh AY, Hwang JW, Na HS, Min SW. Comparison of standard versus 90° 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary First Attempt Success Rate the first attempt success rate of insertion of LMA FlexibleTM at induction
Secondary Insertion Time time from passed mouth of the device to the effective ventilation after inflation of the cuff at induction
Secondary Oropharyngeal Leak Pressure audible leak during manual ventilation at mouth at induction
Secondary 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
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