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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04390893
Enrollment
104
Registered
2020-05-18
Start date
2021-04-01
Completion date
2021-10-31
Last updated
2021-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Mask

Keywords

ultrasound, air leakage test, bronchofiberscope

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

Interventions

DEVICEultrasound

Anesthesiologist would scan three planes of the neck to position the LMA

DIAGNOSTIC_TESTair leakage test

Anesthesiologist would use air leakage test to position the LMA

Sponsors

Shenzhen Second People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Complications related to LMA (laryngeal mask airway )24 hours after surgerysuch as reflection of tussis, sore throat, hoarseness, bleeding and so on

Countries

China

Contacts

Primary ContactLi Xiong, master
levender14@163.com+86-13510602774

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026