Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test
1 other identifier
interventional
104
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedApril 6, 2021
April 1, 2021
4 months
May 13, 2020
April 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Complications related to LMA (laryngeal mask airway )
24 hours after surgery
Study Arms (2)
ultrasound positioning group
EXPERIMENTALleak test positioning group
ACTIVE COMPARATORInterventions
Anesthesiologist would scan three planes of the neck to position the LMA
Anesthesiologist would use air leakage test to position the LMA
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
Related Publications (6)
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.
PMID: 27687463RESULTPerez-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.
PMID: 29970248RESULTOsman 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.
PMID: 27529028RESULTZhou 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.
PMID: 25748523RESULTKim 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.
PMID: 25545750RESULTGhai 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.
PMID: 21689206RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Anesthesiology Department
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 18, 2020
Study Start
April 1, 2021
Primary Completion
July 31, 2021
Study Completion
October 31, 2021
Last Updated
April 6, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share