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

S

Shenzhen University

Status

Unknown

Conditions

Laryngeal Mask

Treatments

Device: ultrasound
Diagnostic Test: air leakage test

Study type

Interventional

Funder types

Other

Identifiers

NCT04390893
2019-12-07

Details and patient eligibility

About

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

Enrollment

104 estimated patients

Sex

All

Ages

17 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

104 participants in 2 patient groups

ultrasound positioning group
Experimental group
Treatment:
Device: ultrasound
leak test positioning group
Active Comparator group
Treatment:
Diagnostic Test: air leakage test

Trial contacts and locations

1

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Central trial contact

Li Xiong, master

Data sourced from clinicaltrials.gov

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