UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061918 |
|---|---|
| Receipt number | R000070852 |
| Scientific Title | Feasibility and safety of the Snorkel Technique for pediatric anesthesia induction: a prospective pilot study |
| Date of disclosure of the study information | 2026/06/16 |
| Last modified on | 2026/06/15 18:52:08 |
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Basic information
Public title
Feasibility and safety of the Snorkel Technique for pediatric anesthesia induction: a prospective pilot study
Acronym
Feasibility and safety of the Snorkel Technique for pediatric anesthesia induction: a prospective pilot study
Scientific Title
Feasibility and safety of the Snorkel Technique for pediatric anesthesia induction: a prospective pilot study
Scientific Title:Acronym
Feasibility and safety of the Snorkel Technique for pediatric anesthesia induction: a prospective pilot study
Region
| Japan |
Condition
Condition
Pediatric patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility, acceptability, and safety of the snorkel technique for induction of general anesthesia in children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients who achieved loss of consciousness using the snorkel technique alone during inhalational induction of anesthesia
Key secondary outcomes
Incidence of peripheral oxygen saturation (SpO2) below 94%, incidence of adverse events (laryngospasm, airway obstruction), Preoperative anxiety level (Japanese modified Yale Preoperative Anxiety Scale: J-mYPAS), Induction compliance assessment (Induction Compliance Checklist: ICC), Parental anxiety level (State-Trait Anxiety Inventory-Form JYZ), Satisfaction level of the parents.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Inhalational induction of anesthesia will be performed using a snorkel-type device rather than a conventional face mask.
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
| 7 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged 7-12 years scheduled for elective surgery under general anesthesia
Key exclusion criteria
American Society of Anesthesiologists physical status III or higher, Patients for whom written informed consent could not be obtained from the patient and/or a parent, Patients with mental retardation, Patients with neuromuscular disorders or a personal or family history of malignant hyperthermia, Patients with a history of upper respiratory tract infection within the past two weeks, Patients with loose teeth, Patients who cannot hold a snorkel or for whom a snorkel does not fit properly
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yusei |
| Middle name | |
| Last name | Ishizuka |
Organization
Tsuruoka Municipal Shonai Hospital
Division name
Department of Anesthesiology
Zip code
9978515
Address
4-20 Izumi-machi, Tsuruoka, Yamagata 997-8515, Japan
TEL
0235265111
y.ishizuka31@gmail.com
Public contact
Name of contact person
| 1st name | Yusei |
| Middle name | |
| Last name | Ishizuka |
Organization
Tsuruoka Municipal Shonai Hospital
Division name
Department of Anesthesiology
Zip code
9978515
Address
4-20 Izumi-machi, Tsuruoka, Yamagata 997-8515, Japan
TEL
0235265111
Homepage URL
y.ishizuka31@gmail.com
Sponsor or person
Institute
Tsuruoka Municipal Shonai Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsuruoka Municipal Shonai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsuruoka Municipal Shonai Hospital Institutional Review Board
Address
4-20 Izumi-machi, Tsuruoka, Yamagata 997-8515, Japan
Tel
0235265111
soumu@shonai-hos.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
鶴岡市立荘内病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 16 | 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
| 2026 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 03 | 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 | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070852
