UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010983 |
|---|---|
| Receipt number | R000012816 |
| Scientific Title | Predictive formula for appropriate endotracheal tube size in preschool-age children |
| Date of disclosure of the study information | 2013/06/17 |
| Last modified on | 2017/06/21 17:37:10 |
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Basic information
Public title
Predictive formula for appropriate endotracheal tube size in preschool-age children
Acronym
Predictive formula for appropriate endotracheal tube size in preschool-age children
Scientific Title
Predictive formula for appropriate endotracheal tube size in preschool-age children
Scientific Title:Acronym
Predictive formula for appropriate endotracheal tube size in preschool-age children
Region
| Japan |
Condition
Condition
preshoool-age children in pediatric surgery such as inguinal hernia and cryptorchidism fusion in head and neck median fixed
Classification by specialty
| Pediatrics | Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cole formula used more than half a century dosen't work well now. We investigate the new formula with a lot of parameters.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Tubes were replaced as necessary until a good clinical fit was obtained. We seek the significant factors among a lot of parameters such as 1.month old, 2.height, 3.weight, 4.via chest X-ray photo,two tracheal diameters, 5.via ultrasonography, the subglottic upper airway diameter, 6.gestational age, 7.weight at birth.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To investigate the most relevant factors to decide an appropriate size of the tracheal tube during general anesthesia in children
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
| 1 | years-old | <= |
Age-upper limit
| 7 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Written consent is obtained
Head of the median position
supine position
Key exclusion criteria
Severely retarded children
Positions other than supine
Positions after bending and forward bending of the head
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oi Yumiko |
Organization
National Mie Hospital
Division name
Anesthesiology
Zip code
Address
Oosatokubota cho 357,Tsu city, Mie Pref.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Oi Yumiko |
Organization
National Mie Hospital
Division name
Anesthesiology
Zip code
Address
059-232-2531
TEL
Homepage URL
Sponsor or person
Institute
National Mie Hospital
Institute
Department
Personal name
Funding Source
Organization
National Mie Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 06 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 17 | Day |
Last modified on
| 2017 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012816
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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