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Completed

NCT Number: NCT03224611

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

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.

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Key information

Conditions

Laryngeal Mask Airway

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: 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 outcomes

  1. The grade of oropharyngeal view through the fiberoptic assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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