UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017898 |
|---|---|
| Receipt number | R000019062 |
| Scientific Title | Ultrasound Echogram Oriented Anatomical Measurement for Caudal Epidural Anesthesia in Pediatric Patients |
| Date of disclosure of the study information | 2015/06/14 |
| Last modified on | 2016/01/13 01:36:11 |
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Basic information
Public title
Ultrasound Echogram Oriented Anatomical Measurement for Caudal Epidural Anesthesia in Pediatric Patients
Acronym
Ultrasound Echogram Oriented Anatomical Measurement for Caudal Anesthesia in Pediatric Patients
Scientific Title
Ultrasound Echogram Oriented Anatomical Measurement for Caudal Epidural Anesthesia in Pediatric Patients
Scientific Title:Acronym
Ultrasound Echogram Oriented Anatomical Measurement for Caudal Anesthesia in Pediatric Patients
Region
| Japan |
Condition
Condition
scrotal hernia,scrotocele,
phimosis,umbilical hernia,
urethral stenosis,rectal-skin fistula
High anal atresia,hypospadia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Caudal block is easily performed because the landmarks are superficial. However, the pediatric sacral hiatus is small in size and shallow in depth. Under general anesthesia, we evaluated whether the distance from the two superolateral sacral crests increased with growth; whether the triangle, formed between the apex of the sacral hiatus and the superolateral sacral crests, was equilateral; and whether the expansion of the epidural area could be confirmed by ultrasound echogram.
Basic objectives2
Others
Basic objectives -Others
We evaluate whether the triangle, formed between the apex of the sacral hiatus and the superolateral sacral crests, was equilateral; and whether the expansion of the epidural area could be confirmed by ultrasound echogram.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The distance from the two superolateral sacral crests
Key secondary outcomes
Whether the triangle, formed between the apex of the sacral hiatus and the superolateral sacral crests
Whether the expansion of the epidural area could be confirmed by ultrasound echogram.
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
| Device,equipment | Maneuver |
Interventions/Control_1
whether an equilateral triangle was formed between the apex of the sacral hiatus and the bilateral superolateral sacral crests
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
| 0 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Under general anesthesia, the pediatric patients receive the caudal anesthesia
Key exclusion criteria
spina bifida
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Ozaki |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Anesthesia
Zip code
Address
8-1 Kawada-chou Shinjyuku-ku Tokyo Japan
TEL
0333538111
yukako1@rg8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukako Abukawa |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Anesthesia
Zip code
Address
8-1 Kawada-chou Shinjyuku-ku Tokyo Japan
TEL
03-3353-8111
Homepage URL
yukako1@rg8.so-net.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Department of Anesthesia
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
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
| 2015 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Two patients were excluded because the superolateral sacral crests and sacral hiatus could not be palpated. The base of the triangle increased in proportion to age up to 10 years old, with a significant correlation between age and the length of the base. The triangle was not an equilateral triangle under 7 years old. The sacral hiatus could be identified by ultrasound and we could confirm expansion of the epidural space in all patients.
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
Completed
Date of protocol fixation
| 2008 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 05 | 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
| 2015 | Year | 06 | Month | 14 | Day |
Last modified on
| 2016 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019062
