UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061937 |
|---|---|
| Receipt number | R000070864 |
| Scientific Title | Comparative Study of the Effect of the New and Old i-gel Supraglottic Device on Airway Management in the Lateral Supine Position |
| Date of disclosure of the study information | 2026/06/17 |
| Last modified on | 2026/06/17 05:21:34 |
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Basic information
Public title
Comparison of the effect of the use of the i-gel, a supraglottic device, on airway clearance and effectiveness in patients in the lateral position.
Acronym
Lateral position and a supraglottic device
Scientific Title
Comparative Study of the Effect of the New and Old i-gel Supraglottic Device on Airway Management in the Lateral Supine Position
Scientific Title:Acronym
Lateral decubitus position and i-gel
Region
| Japan |
Condition
Condition
Surgical patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The current study aims to investigate the utility of a new i-gel by comparing it with the classic i-gel during mechanical ventilation in the lateral decubitus position.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oropharyngeal leak pressure in the lateral decubitus position
Key secondary outcomes
Expiratory tidal volume and glottic view during mechanical ventilation in the lateral positions
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing a scheduled surgery under general anesthesia
Key exclusion criteria
Patients who preferred tracheal intubation.
Patient without the use of neuromuscular blocking agents.
Patients for whom intravenous anesthetic induction was contraindicated.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kobayashi |
Organization
Seirei Kikataghara General Hospital
Division name
Anesthesiology
Zip code
433-8558
Address
3453 Mikatahara Chuo-ku, Hamamatsu
TEL
053-436-1251
mym96472@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kinoshita |
Organization
Seirei Kikataghara General Hospital
Division name
Anesthesiology
Zip code
433-8558
Address
3453 Mikatahara Chuo-ku, Hamamatsu
TEL
053-436-1251
Homepage URL
hkinoshi@krc.biglobe.ne.jp
Sponsor or person
Institute
Seirei Kikataghara General Hospital
Institute
Department
Personal name
Funding Source
Organization
Seirei Mikatahara General Haspital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Kikataghara General Hospital
Address
3453 Mikatahara Chuo-ku, Hamamatsu
Tel
053-436-1251
hkinoshi@krc.biglobe.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
92
Org. issuing International ID_1
Hidaka Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
ひだか病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
91
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary outcome of the current study was oropharyngeal leak pressure in lateral positions using the i-gelTM and i-gel PlusTM. The secondary outcomes of the current study were expiratory tidal volume and glottic view during mechanical ventilation in the lateral positions using the i-gelTM and i-gel PlusTM.
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070864
