UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060654 |
|---|---|
| Receipt number | R000069376 |
| Scientific Title | Changes in Neck Flexion Angle, Leak Pressure, and Ventilation Performance with i-ge in Anesthetized Adults |
| Date of disclosure of the study information | 2026/02/12 |
| Last modified on | 2026/02/12 15:15:25 |
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Basic information
Public title
Changes in Neck Flexion Angle, Leak Pressure, and Ventilation Performance with i-ge in Anesthetized Adults
Acronym
Changes in Neck Flexion Angle, Leak Pressure, and Ventilation Performance with i-ge in Anesthetized Adults
Scientific Title
Changes in Neck Flexion Angle, Leak Pressure, and Ventilation Performance with i-ge in Anesthetized Adults
Scientific Title:Acronym
Changes in Neck Flexion Angle, Leak Pressure, and Ventilation Performance with i-ge in Anesthetized Adults
Region
| Japan |
Condition
Condition
Patients aged 20 years or older undergoing general anesthesia who require airway management
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Breast surgery |
| Obstetrics and Gynecology | Orthopedics | Urology |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate oropharyngeal leak pressure (OPLP) and ventilatory performance (peak inspiratory pressure, tidal volume, ventilation score) when using the supraglottic airway device i-gel in anesthetized adults, taking into account differences in neck flexion angle.
Basic objectives2
Others
Basic objectives -Others
The effects of cervical angle and the incidence of postoperative complications should also be evaluated.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oropharyngeal Leak Pressure
Key secondary outcomes
Time to success, leak pressure (endotracheal pressure causing air leakage), procedure-related complications (sore throat and hoarseness), tidal volume per breath, peak pressure at 10 ml/kg ventilation, ventilation score (0-3 points), fiberoptic assessment (Brimacombe classification)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Set the head and neck angle in the following three stages: neutral position, mild flexion (15 degrees), mild extension (15 degrees)
Measure the angle using a goniometer
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older undergoing general anesthesia who require airway management
Patients for whom informed consent was obtained through their signature on the consent form for participation in this study
Key exclusion criteria
Refusal to participate in the study
Same-day surgery
Existing neurological or cognitive impairment
Use of antipsychotic medications
BMI (body mass index) exceeding 35 kg/m2 or body weight exceeding 90 kg
Mouth opening less than 2.5 cm
Acute sore throat
Conditions with 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/neck surgery)
Target sample size
40
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
053-436-1251
Homepage URL
shingogo@hama-med.ac.jp
Sponsor or person
Institute
Seirei Mikatahara General Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
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 | 12 | 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
| 2026 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069376
