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

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 Overview

• Status: Recruiting
• Conditions: Laryngeal Mask
• Intervention / Treatment: Device: ultrasound; Diagnostic test: air leakage test

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Xiong, master; Phone Number: +86-13510602774; Email: levender14@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518035
      • Recruiting
      • Shenzhen Second People's Hospital
      • Contact: Li Xiong; Phone Number: +8613510602774; Email: levender14@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultrasound positioning group	Device: ultrasound; Anesthesiologist would scan three planes of the neck to position the LMA
Active Comparator: leak test positioning group	Diagnostic test: air leakage test; Anesthesiologist would use air leakage test to position the LMA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital

Publications and helpful links

General Publications

• 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.
• Perez-Herrero MA, de la Varga O, Flores M, Sanchez-Ruano J, Otero M, Buisan F. Descriptive study of ultrasound images of the upper airway obtained after insertion of laryngeal mask. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):434-440. doi: 10.1016/j.redar.2018.05.004. Epub 2018 Jun 30. English, Spanish.
• 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.
• 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.ultrasmedbio.2014.12.002. Epub 2015 Mar 5.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: ultrasound; air leakage test; bronchofiberscope
• Other Study ID Numbers: 2019-12-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No