Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway

Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway: Comparison With Conventional Blind-insertion

Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to insert in correct position because of it's flexible structure. Especially in classical way of manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal position, we could not guarantee the correct position of the LMA. Therefore several studies have been investigated to improve this.

The light wand is a kind of stylet which have a light on the tip. Recently some studies demonstrated the usefulness of the light wand which could be used for indicating correct position of the LMA. We hypothesised there will be two advantages if the light wand is used as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible LMA, and second the lightness could confirm the correct position of the flexible LMA.

Study Overview

• Status: Completed
• Conditions: Laryngeal Mask Airway
• Intervention / Treatment: Device: light wand

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggido
    • Suwon, Gyeonggido, Korea, Republic of
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient need general anesthesia using LMA and belonged to the ASA(American society of Anesthesiologist) class I or II

Exclusion Criteria:

• The patient who has URI(upper respiratory infection) symptom within 14 days or
• The patient's BMI(body mass index) exceeds 35 kg/m2
• The patient has severe GERD(gastroesophageal reflux disease) or hiatus hernia
• The patient who has any contraindication for LMA insertion

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
No Intervention: Control group; The flexible LMA is inserted using "index finger technique"
Active Comparator: Light wand group; The flexible LMA is inserted using light wand as a stylet	Device: light wand; The light wand is used as a stylet of the flexible LMA. When the investigator inserts the flexible LMA in "light wand group", the correct position of the LMA is confirmed by the light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressure	The oropharyngeal leak pressure is measured by the pressure which the investigator could detect the audible sound by stethoscope on patient's cheek during the exhaust valve is closed and the fresh gas is allowed to flow into the lungs at 3 liters per minute.	5 minutes after LMA is inserted

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The grade of oropharyngeal view through the fiberoptic assessment	The position of the LMA was assessed by fiberoptic examination through an attachment between the LMA and the anesthetic circuit.	5 minutes after LMA is inserted

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Ji Young Yoo, Clinical Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AJIRB-MED-OBS-17-108

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