Effect of Head Elevation on LMA Insertion

Not Applicable

Completed

• Conditions: Urinary Bladder Neoplasms; Laryngeal Masks
• Interventions: Procedure: Laryngeal mask airway insertion

• Registration Number: NCT04229862
• Lead Sponsor: Asan Medical Center

Brief Summary

The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion according to the degree of head elevation.

Detailed Description

The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion between 7 cm head elevation and 14 cm head elevation in patients who undergoing transurethral bladder tumor resection.

Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-02-14
• Primary Completion: 2020-04-05
• Status Verified: 2020-05
• Study Completion: 2020-05-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients who are scheduled transurethral bladder tumor resection under general anesthesia
• 20-79 years of age
• American Society of Anesthesiologists physical status ≤3
• Patients who are voluntarily agreed to this clinical study

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Exclusion Criteria

• History of difficult airway
• Expected difficult airway by physical examination
• Unstable teeth or teeth loss
• Obesity (body mass index ≥ 30)
• Recent history of upper respiratory infection
• Patients who are not fasted or who are at risk of aspiration

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evaluation with 14 cm high pillow	Laryngeal mask airway insertion	When inserting laryngeal mask airway, head elevation is performed using a 14 cm high pillow.
Evaluation with 7 cm high pillow	Laryngeal mask airway insertion	When inserting laryngeal mask airway, head elevation is performed using a 7 cm high pillow.

Primary Outcome Measures

Name	Time	Method
First attempt success rate	Immediately after mask airway insertion	The rate of success at the first attempt of laryngeal mask airway insertion

Secondary Outcome Measures

Name	Time	Method
The percentage of glottic opening score	Immediately after mask airway insertion	The percentage of glottic opening by fiberoptic view
Laryngeal mask airway insertion-related patient satisfaction	At postoperative 6 hours	A seven-point Likert scale
Oropharyngeal leak pressure	Immediately after mask airway insertion	Oropharyngeal leak pressure is measured as follows: After setting the expiratory valve to 30 cmH2O at a fixed gas flow rate of 3 L/min, the maximum inflation pressure is measured when a noise of gas leakage is heard in the oropharynx via a stethoscope.
Reposition rate	After mask airway insertion (up to end of surgery)	The rate of reposition after laryngeal mask airway insertion when ventilation is ineffective or air leaks
Second attempt success rate	Immediately after mask airway insertion	The rate of success at the second attempt of laryngeal mask airway insertion
Third attempt success rate	Immediately after mask airway insertion	The rate of success at the third attempt of laryngeal mask airway insertion
Complications associated with laryngeal mask airway insertion	Up to postoperative 3 days	Complications related with laryngeal mask airway insertion such as cough, vomit, aspiration, regurgitation, bleeding, laryngospasm, and bronchospasm

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of