Clinical trial NCT04390893: Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test
Official title: Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngeal Mask
Keywords: ultrasound
air leakage test
bronchofiberscope
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 104
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasound scoring system
timeFrame: during procedure (after laryngeal mask's placement)
measure: Air leakage test grading system
timeFrame: during procedure (after laryngeal mask's placement)
measure: Fiberoptic scoring system
timeFrame: procedure (after ultrasound examination or leakage test)
Secondary outcomes:
measure: Complications related to LMA (laryngeal mask airway )
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
References:
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.
citation: 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.
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.
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.ultrasmedbio.2014.12.002. Epub 2015 Mar 5.
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.
citation: 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.