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

Not Applicable

• Conditions: Laryngeal Mask
• Interventions: Device: ultrasound; Diagnostic Test: air leakage test

• Registration Number: NCT04390893
• Lead Sponsor: Shenzhen Second People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Status Verified: 2021-04
• Study Start: 2021-04-01
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-06
• Primary Completion: 2021-07-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• patients selected for this study must meet all of the following criterion:

  1. Age is between 17 to 65 years old;
  2. ASA (Amecican Society of Anesthesiology ) scores I-II;
  3. Actual weight is between 30 to 100 kilogram;
  4. Patients undergo selective supine operations under general anesthesia (laryngeal mask);
  5. 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:

  1. Airway stenosis, history of airway masses etc, whicn may cause obstruction to ventilation;
  2. Swelling of the neck caused by huge mass in the neck and history of neck surgery etc, which doesn't contribute to ultrasound observation;
  3. Stomach fullness, intestinal obstruction, gastroesophageal reflux disease etc, which may cause reflux aspiration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound positioning group	ultrasound	-
leak test positioning group	air leakage test	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Complications related to LMA (laryngeal mask airway )	24 hours after surgery	such as reflection of tussis, sore throat, hoarseness, bleeding and so on

Trial Locations

Locations (1)

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China