UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050035 |
|---|---|
| Receipt number | R000057000 |
| Scientific Title | Randomized Comparison of Depth Marking and Ultrasound-Guided Measurement of Optimal Tracheal Tube Position |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/07/16 09:02:22 |
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Basic information
Public title
Ultrasound study of appropriate tube position for pediatric cuffed tracheal tubes
Acronym
Appropriate Tube Positioning for Pediatric Cuffed Tracheal Tubes
Scientific Title
Randomized Comparison of Depth Marking and Ultrasound-Guided Measurement of Optimal Tracheal Tube Position
Scientific Title:Acronym
Randomized controlled trial of optimal location of tracheal tubes
Region
| Japan |
Condition
Condition
Pediatric patients scheduled for general anesthesia
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In pediatric tracheal intubation, it is important to position the end of the tracheal tube in the middle of the trachea. Several formulas have been used to predict the insertion length of a tracheal tube, but none is perfect. Our objective is to identify the optimal position of the tracheal tube tip under ultrasound guidance for safe tracheal tube insertion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of optimal position of tracheal tube
Key secondary outcomes
The position of the cuff and the optimal depth of the tracheal tube should be related to the patient's age, height, and weight.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Place tracheal tube in appropriate position under ultrasound use
Interventions/Control_2
Depth marking method
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
| 1 | days-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients scheduled for general anesthesia
Key exclusion criteria
If the study subject refuses to participate, or if the patient is at high airway risk or has anatomical malformations in the airway system
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Mao |
| Middle name | |
| Last name | Kinoshita |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
602-8566
Address
Kajiicho 465 Kamigyo-Ku Kyoto
TEL
075-251-5633
mao6515@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Mao |
| Middle name | |
| Last name | Kinoshita |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
602-8566
Address
Kajiicho 465 Kamigyo-Ku Kyoto
TEL
075-251-5633
Homepage URL
mao6515@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Kinoshita Mao
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Kyoto Prefectural University of Medicine
Other related organizations
Co-sponsor
Kyoto Prefectural University of Medicine
Name of secondary funder(s)
Kyoto Prefectural University of Medicine
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kajiicho 465 Kamigyo-Ku Kyoto
Tel
0752515633
mao6515@koto.kpu-m.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
| 2023 | Year | 05 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 14 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057000
