Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Ultrasound scoring system
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Ultrasound scoring system
Time Frame: during procedure (after laryngeal mask's placement)
Anesthesiologist who are familiar with ultrasound would scan three planes of neck
Air leakage test grading system
Time Frame: during procedure (after laryngeal mask's placement)
Anesthesiologist would auscultate the degree of leakage
Fiberoptic scoring system
Time Frame: procedure (after ultrasound examination or leakage test)
Anesthesiologist would confirm the position of LMA by fiberscope
Secondary Outcomes
- Complications related to LMA (laryngeal mask airway )(24 hours after surgery)
Investigators
ZhiHeng Liu
Head of Anesthesiology Department
Shenzhen Second People's Hospital