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

Laryngeal Mask Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04390893
• Other study ID #: 2019-12-07
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2021
• Source: Shenzhen Second People's Hospital
• Contact: Li Xiong, master
• Phone: +86-13510602774
• Email: levender14[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: October 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laryngeal Mask

Intervention

Device:
• ultrasound
Anesthesiologist would scan three planes of the neck to position the LMA

Diagnostic Test:
• air leakage test
Anesthesiologist would use air leakage test to position the LMA

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Ghai B, Ram J, Makkar JK, Wig J. Fiber-optic assessment of LMA position in children: a randomized crossover comparison of two techniques. Paediatr Anaesth. 2011 Nov;21(11):1142-7. doi: 10.1111/j.1460-9592.2011.03632.x. Epub 2011 Jun 21. — View Citation

Kim J, Kim JY, Kim WO, Kil HK. An ultrasound evaluation of laryngeal mask airway position in pediatric patients: an observational study. Anesth Analg. 2015 Feb;120(2):427-32. doi: 10.1213/ANE.0000000000000551. — View Citation

Osman A, Sum KM. Role of upper airway ultrasound in airway management. J Intensive Care. 2016 Aug 15;4:52. doi: 10.1186/s40560-016-0174-z. eCollection 2016. Review. — View Citation

Pérez-Herrero MA, de la Varga O, Flores M, Sánchez-Ruano J, Otero M, Buisán F. Descriptive study of ultrasound images of the upper airway obtained after insertion of laryngeal mask. Rev Esp Anestesiol Reanim. 2018 Oct;65(8):434-440. doi: 10.1016/j.redar.2 — View Citation

Song K, Yi J, Liu W, Huang S, Huang Y. Confirmation of laryngeal mask airway placement by ultrasound examination: a pilot study. J Clin Anesth. 2016 Nov;34:638-46. doi: 10.1016/j.jclinane.2016.06.019. Epub 2016 Aug 3. — View Citation

Zhou ZF, Xia CZ, Wu M, Yu LN, Yan GZ, Ren QS, Hu CX, Yan M. Comparison of three methods for the confirmation of laryngeal mask airway placement in female patients undergoing gynecologic surgery. Ultrasound Med Biol. 2015 May;41(5):1212-20. doi: 10.1016/j. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound scoring system	Anesthesiologist who are familiar with ultrasound would scan three planes of neck	during procedure (after laryngeal mask's placement)
Primary	Air leakage test grading system	Anesthesiologist would auscultate the degree of leakage	during procedure (after laryngeal mask's placement)
Primary	Fiberoptic scoring system	Anesthesiologist would confirm the position of LMA by fiberscope	procedure (after ultrasound examination or leakage test)
Secondary	Complications related to LMA (laryngeal mask airway )	such as reflection of tussis, sore throat, hoarseness, bleeding and so on	24 hours after surgery