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

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03224611

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laryngeal Mask Airway	Device: light wand	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Oropharyngeal leak pressure [5 minutes after LMA is inserted]
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.

Secondary Outcome Measures

The grade of oropharyngeal view through the fiberoptic assessment [5 minutes after LMA is inserted]
The position of the LMA was assessed by fiberoptic examination through an attachment between the LMA and the anesthetic circuit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Suwon	Gyeonggido	Korea, Republic of

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

Principal Investigator: Ji Young Yoo, Clinical assistant professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiyoung Yoo, clinical assistant professor, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT03224611

Other Study ID Numbers:

AJIRB-MED-OBS-17-108

First Posted:

Jul 21, 2017

Last Update Posted:

Oct 17, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 17, 2018