Videoscope Guided Flexible LMA Insertion

Videoscope Guided Flexible LMA Insertion : Comparison With Blind Insertion

Laryngeal Mask Airway Flexible (LMA Flexible) is useful in various surgery because of its unique design. The flexometallic tube allows it could be used in head and neck related surgery but also make insertion more difficult. The ideal position of LMA Flexible is important because in most case, the surgery requiring LMA Flexible allows movements of the stem or patient's head during operation without dislodgement of LMA Flexible. Several studies have examined different techniques like assisting LMA Flexible with rigid introducers or lifting epiglottis with direct laryngoscope. But there is no study using videolaryngoscope (VL) for LMA Flexible insertion. The investigator hypothesized that McGrath(McGRATH™ MAC video laryngoscope;Aircraft Medical Ltd, UK.), one kind of the VL, assisted insertion would increase the success rate of LMA Flexible insertion by lifting epiglottis and securing a view while LMA Flexible is seated. The aim of this study was to investigate the efficacy of the McGrath VL assisted insertion of LMA Flexible compared with the standard method of digital manipulation technique in regard to the ideal anatomical position and sealing pressure in anesthetized adult patients.

Study Overview

• Status: Completed
• Conditions: Ideal Position of LMA Flexible
• Intervention / Treatment: Device: Control; Device: Mcgrath

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyunggido
    • Suweon, Kyunggido, Korea, Republic of, 443-380
      • Jiyoung Yoo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA (American society of anesthesiologist) physical status classification system I and II,
• scheduled to elective general anesthesia with the use of LMA

Exclusion Criteria:

• suspected difficult airway
• a history of a recent upper airway tract infection
• gastroesophageal reflux
• body mass index > 30 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Device: Control; Digital manipulation technique of LMA flexible insertion
Experimental: McGrath group	Device: Mcgrath; McGrath assisted insertion of LMA flexible

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ideal positioning rate of LMA flexible	3 minute after LMA flexible insertion

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AJIRB-DEV-OBS-16-444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No