Videoscope Guided Flexible LMA Insertion

NCT03510299 | Completed

• 1 other identifier: AJIRB-DEV-OBS-16-444
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ideal Position of LMA Flexible

Outcome Measures

Primary Outcomes (1)

• Ideal positioning rate of LMA flexible

  3 minute after LMA flexible insertion

Study Arms (2)

Control group

PLACEBO COMPARATOR

Device: Control

McGrath group

EXPERIMENTAL

Device: Mcgrath

Interventions

Mcgrath DEVICE

McGrath assisted insertion of LMA flexible

McGrath group

Control DEVICE

Digital manipulation technique of LMA flexible insertion

Control group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Jiyoung Yoo

Suweon, Kyunggido, 443-380, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 27, 2018
• Study Start: January 20, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)