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

Laryngeal Mask Airway Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224611
• Other study ID #: AJIRB-MED-OBS-17-108
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Mask Airway

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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