UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010690 |
|---|---|
| Receipt number | R000012497 |
| Scientific Title | Validation of new training method for radial artery catheterization in adult patients |
| Date of disclosure of the study information | 2013/05/10 |
| Last modified on | 2016/01/26 07:03:08 |
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Basic information
Public title
Validation of new training method for radial artery catheterization in adult patients
Acronym
Validation of new training method for radial artery catheterization in adult patients
Scientific Title
Validation of new training method for radial artery catheterization in adult patients
Scientific Title:Acronym
Validation of new training method for radial artery catheterization in adult patients
Region
| Japan |
Condition
Condition
Adult pateints are performed elective surgeries
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate new training method for radial artery catheterization in adult patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate and puncture duration of radial artery catheterization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
new training method (15 minutes/day for 7 days) with ultrasound-guidance and aneroid sphygmomanometer
Interventions/Control_2
clinical training of anesthesia as usual
and not having new training 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients (ASA-PS 1,2) are performed elective surgery and scheduled direct measurement of arterial pressure in Kyoto prefectural university of medicine
Clinical trainees in in Kyoto prefectural university of medicine
Key exclusion criteria
Adult patients and clinical trainees are not got consents.
Adult patients of emergency cases or above ASA-PS 3
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Mizobe |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
+81-75-251-5633
na-yoshi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Nakayama |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
+81-75-251-5633
Homepage URL
na-yoshi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Anesthesiology,Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 05 | Month | 10 | 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
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
| 2013 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 12 | 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 | 05 | Month | 10 | Day |
Last modified on
| 2016 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012497
