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OpenTrials
Completed

NCT Number: NCT03028896

90° Rotation Technique for LMA FlexibleTM Insertion

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.

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Key information

Conditions

Laryngeal Masks

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

90° rotational technique

Procedure

the LMA FlexibleTM was rotated counter-clockwise through 90°

Primary outcomes

  1. First Attempt Success Rate

    Time frame: at induction

    the first attempt success rate of insertion of LMA FlexibleTM

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 23, 2017
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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