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

NCT03224611 | Completed

• 1 other identifier: AJIRB-MED-OBS-17-108
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The grade of oropharyngeal view through the fiberoptic assessment

  5 minutes after LMA is inserted

Study Arms (2)

Control group

NO INTERVENTION

The flexible LMA is inserted using "index finger technique"

Light wand group

ACTIVE COMPARATOR

The flexible LMA is inserted using light wand as a stylet

Device: light wand

Interventions

light wand DEVICE

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.

Light wand group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Location

Study Officials

• Ji Young Yoo

  Clinical assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 21, 2017
• Study Start: August 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)