UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060024 |
|---|---|
| Receipt number | R000068649 |
| Scientific Title | A Study on the Relationship Between Preoperative Laryngeal Ultrasound Findings and the Optimal Insertion Position of a Laryngeal Mask |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/09 11:57:50 |
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Basic information
Public title
A Study on the Relationship Between Preoperative Laryngeal Ultrasound Findings and the Optimal Insertion Position of a Laryngeal Mask
Acronym
Correlation between Neck Ultrasound Findings and Laryngeal Mask Insertion Position
Scientific Title
A Study on the Relationship Between Preoperative Laryngeal Ultrasound Findings and the Optimal Insertion Position of a Laryngeal Mask
Scientific Title:Acronym
Correlation between Neck Ultrasound Findings and Laryngeal Mask Insertion Position
Region
| Japan |
Condition
Condition
General Anesthesia Cases with Airway Management Using a Laryngeal Mask
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate preoperative laryngeal parameters and temporomandibular joint mobility using ultrasound imaging to investigate their relationship with the optimal position of the laryngeal mask airway (LMA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prior to anesthesia, measure various indicators via laryngeal ultrasound (hyoid bone width, depth of epiglottis from skin, mandibular condyle displacement during mouth opening).
To evaluate the position of the laryngeal mask under bronchoscopy. A score of 3 or higher is considered
Key secondary outcomes
After induction of anesthesia, perform a leak test once stable.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases aged 18 years or older managed with LM under general anesthesia at our hospital
Key exclusion criteria
Patient refusal
Cervical spine pathology
Severe cardiovascular disease
Unstable teeth
Anatomical airway abnormalities
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata Prefectural Tokamachi Hospital
Division name
Department of Anesthesiology
Zip code
948-0065
Address
3-32-9 Minami, Takada-cho, Tokamachi City, Niigata Prefecture
TEL
0257575566
seijihida@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata Prefectural Tokamachi Hospital
Division name
Department of anesthesiology
Zip code
9480065
Address
3-32-9 Minami, Takada-cho, Tokamachi City, Niigata Prefecture
TEL
0257575566
Homepage URL
seijihida@yahoo.co.jp
Sponsor or person
Institute
Niigata Prefectural Tokamachi Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata Prefectural Tokamachi Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata Prefectural Tokamachi Hospital
Address
3-32-9 Minami, Takada-cho, Tokamachi City, Niigata Prefecture
Tel
0257575566
seijihida@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The laryngeal mask (LM) is routinely used as an airway management device in general anesthesia cases. When the LM is not positioned correctly, it is thought to significantly increase the risk of gastric insufflation, aspiration, and inadequate ventilation. The reported rate of improper LM positioning ranges from 30 to 66%. Recent studies have suggested the potential of ultrasound for evaluating proper LM placement. While associations between laryngeal echo findings and difficult intubation have been reported, no studies have examined the relationship between these indicators and proper LM placement. Therefore, we planned to perform various measurements and evaluate temporomandibular joint mobility using laryngeal echo preoperatively to investigate the correlation with proper LM placement.
Management information
Registered date
| 2025 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068649
