Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test

Study Overview
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Brief Summary
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Compare the accuracy of two methods of ultrasound and air leakage test in positioning laryngeal mask. Validate the relationship between ultrasound scores, air leak levels, and bronchoscopic classification in positioning laryngeal mask

Official Title
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Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test: A Randomized Controlled Trial

Conditions
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Laryngeal Mask

Intervention / Treatment
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* Device: ultrasound
* Diagnostic Test: air leakage test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients selected for this study must meet all of the following criterion: Age is between 17 to 65 years old; ASA (Amecican Society of Anesthesiology ) scores I-II; Actual weight is between 30 to 100 kilogram; Patients undergo selective supine operations under general anesthesia (laryngeal mask); Patients agree to participate in our study and sign Informed Consent Form Exclusion Criteria: Patients cannot participate in this study if they have any of the following conditions: Airway stenosis, history of airway masses etc, whicn may cause obstruction to ventilation; Swelling of the neck caused by huge mass in the neck and history of neck surgery etc, which doesn't contribute to ultrasound observation; Stomach fullness, intestinal obstruction, gastroesophageal reflux disease etc, which may cause reflux aspiration.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasound positioning group<br> | Device: ultrasound<br>* Anesthesiologist would scan three planes of the neck to position the LMA<br>|
| Active Comparator: leak test positioning group<br> | Diagnostic Test: air leakage test<br>* Anesthesiologist would use air leakage test to position the LMA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound scoring system | Anesthesiologist who are familiar with ultrasound would scan three planes of neck | during procedure (after laryngeal mask's placement) | 
| Air leakage test grading system | Anesthesiologist would auscultate the degree of leakage | during procedure (after laryngeal mask's placement) | 
| Fiberoptic scoring system | Anesthesiologist would confirm the position of LMA by fiberscope | procedure (after ultrasound examination or leakage test) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to LMA (laryngeal mask airway ) | such as reflection of tussis, sore throat, hoarseness, bleeding and so on | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, air leakage test, bronchofiberscope