Laryngeal MaskNCT04390893
Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test
A study testing ultrasound and air leakage test in people with Laryngeal Mask, run by Shenzhen Second People's Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Laryngeal Mask
- What is being tested?
- ultrasound and air leakage test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Li Xiong, +8613510602774, levender14@163.com
About this study
Official title: 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
- Conditions
- Laryngeal Mask
- Being tested
- ultrasound, air leakage test
- Keywords
- ultrasound, air leakage test, bronchofiberscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Anesthesiologist would scan three planes of the neck to position the LMA
air leakage testDiagnostic test
Anesthesiologist would use air leakage test to position the LMA
| Study group | Role | What they receive |
|---|---|---|
| ultrasound positioning group | Experimental | Not described Receives: Device: ultrasound |
| leak test positioning group | Active comparator | Not described Receives: Diagnostic Test: air leakage test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound scoring system
Anesthesiologist who are familiar with ultrasound would scan three planes of neck
Measured: during procedure (after laryngeal mask's placement)
Air leakage test grading system
Anesthesiologist would auscultate the degree of leakage
Measured: during procedure (after laryngeal mask's placement)
Fiberoptic scoring system
Anesthesiologist would confirm the position of LMA by fiberscope
Measured: procedure (after ultrasound examination or leakage test)
Secondary outcomes (1)
Complications related to LMA (laryngeal mask airway )
such as reflection of tussis, sore throat, hoarseness, bleeding and so on
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Apr 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Laryngeal MaskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhiHeng Liu, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390893
- Sponsor's protocol ID
- 2019-12-07
- Status last verified
- Apr 2021
- First submitted
- 13 May 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27687463Perez-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.
PubMed 29970248Osman 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.
PubMed 27529028Zhou 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.
PubMed 25748523Kim 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.
PubMed 25545750Ghai 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.
PubMed 21689206
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04390893
- Acronym / sponsor ID
- 2019-12-07
- Conditions
- Laryngeal Mask
- Keywords
- ultrasound, air leakage test, bronchofiberscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound positioning group | Experimental | Device: ultrasound |
| leak test positioning group | Active comparator | Diagnostic Test: air leakage test |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- patients selected for this study must meet all of the following criterion:
Key exclusion criteria (4 listed)
- Patients cannot participate in this study if they have any of the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundAnesthesiologist would scan three planes of the neck to position the LMA | Device | ultrasound positioning group |
| air leakage testAnesthesiologist would use air leakage test to position the LMA | Diagnostic test | leak test positioning group |
Primary outcome
Ultrasound scoring system
Time frame: during procedure (after laryngeal mask's placement)
Anesthesiologist who are familiar with ultrasound would scan three planes of neck
Air leakage test grading system
Time frame: during procedure (after laryngeal mask's placement)
Anesthesiologist would auscultate the degree of leakage
Fiberoptic scoring system
Time frame: procedure (after ultrasound examination or leakage test)
Anesthesiologist would confirm the position of LMA by fiberscope
1 secondary outcome
Complications related to LMA (laryngeal mask airway )
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Results publication: PubMed 27687463Song 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.
- Results publication: PubMed 29970248Perez-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.
- Results publication: PubMed 27529028Osman 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.
- Results publication: PubMed 25748523Zhou 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.
- Results publication: PubMed 25545750Kim 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.
- Results publication: PubMed 21689206Ghai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and air leakage test in people with Laryngeal Mask, run by Shenzhen Second People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Xiong, master (+86-13510602774, levender14@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound scoring system (time frame: during procedure (after laryngeal mask's placement)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390893, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.