UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059553 |
|---|---|
| Receipt number | R000068118 |
| Scientific Title | Comparison of the Effectiveness of Mandibular Elevation Technique and Conventional Method in i-gel Insertion: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2025/10/27 17:24:43 |
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Basic information
Public title
Comparison of the Effectiveness of Mandibular Elevation Technique and Conventional Method in i-gel Insertion: A Randomized Controlled Trial
Acronym
Comparison of the Effectiveness of the Mandibular Elevation Technique and the Conventional Method in i-gel Insertion
Scientific Title
Comparison of the Effectiveness of Mandibular Elevation Technique and Conventional Method in i-gel Insertion: A Randomized Controlled Trial
Scientific Title:Acronym
Comparison of the Effectiveness of the Mandibular Elevation Technique and the Conventional Method in i-gel Insertion
Region
| Japan |
Condition
Condition
Patients Under General Anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The significance of this study is to reduce ventilation failure and the need for intubation due to insertion failure, thereby improving the safety of anesthesia management. From an educational perspective, establishing a reproducible technique for beginners is important. Verifying the usefulness of the mandibular elevation method as an alternative to the standard method may contribute to future anesthesia education and clinical guideline revisions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First-Attempt Success Rate of Insertion
Key secondary outcomes
Success rate within two attempts
Time required for successful insertion within two attempts
Leak pressure
Conversion to tracheal intubation
Procedure-related complications assessed in the post-anesthesia care unit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
During insertion, the i-gel is inserted while lifting the mandible along with the tongue using one hand to create space in the oral cavity.
Interventions/Control_2
Without rotating the head, the i-gel is inserted in the sniffing position by pushing the patient's chin forward to open the mouth, and advancing it along the hard palate into the oral cavity.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 50 years or older undergoing general anesthesia who require airway management.
Patients who provided consent to participate in this study by signing a written informed consent form.
[Justification] Since insertion difficulties with the i-gel are rare in younger individuals, the age criterion was set at 50 years or older.
Key exclusion criteria
Refusal to participate in the study
Day surgery
Pre-existing neurological or cognitive disorders
Use of antipsychotic medications
Body mass index (BMI) over 35 kg/m2 or body weight over 90 kg
Mouth opening less than 2.5 cm
Acute sore throat
Conditions with a risk of aspiration (e.g., pregnancy, gastroesophageal reflux disease, hiatal hernia)
History of difficult intubation
Limited neck mobility (e.g., atlantoaxial subluxation, history of cervical spine or head and neck surgery)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | shingo |
| Middle name | |
| Last name | kawashima |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Anesthesiology
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu Shizuoka
TEL
+81-53-436-1251
shingogo@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | shingo |
| Middle name | |
| Last name | kawashima |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Anesthesiology
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu Shizuoka
TEL
0534361251
Homepage URL
shingogo@hama-med.ac.jp
Sponsor or person
Institute
Seirei Mikatahara General Hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Mikatahara General Hospital
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu
Tel
+81-53-436-1251
shingogo@hama-med.ac.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
| 2026 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068118
