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

NCT ID: NCT04390893

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Laryngeal Mask

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ultrasound positioning group

Group Type EXPERIMENTAL

ultrasound

Intervention Type DEVICE

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

leak test positioning group

Group Type ACTIVE_COMPARATOR

air leakage test

Intervention Type DIAGNOSTIC_TEST

Anesthesiologist would use air leakage test to position the LMA

Interventions

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ultrasound

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

Intervention Type DEVICE

air leakage test

Anesthesiologist would use air leakage test to position the LMA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Second People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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ZhiHeng Liu

Head of Anesthesiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Xiong, master

Role: CONTACT

+86-13510602774

Facility Contacts

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Li Xiong

Role: primary

+8613510602774

References

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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.

Reference Type RESULT
PMID: 27687463 (View on PubMed)

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.

Reference Type RESULT
PMID: 29970248 (View on PubMed)

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.

Reference Type RESULT
PMID: 27529028 (View on PubMed)

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.

Reference Type RESULT
PMID: 25748523 (View on PubMed)

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.

Reference Type RESULT
PMID: 25545750 (View on PubMed)

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.

Reference Type RESULT
PMID: 21689206 (View on PubMed)

Other Identifiers

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2019-12-07

Identifier Type: -

Identifier Source: org_study_id

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