UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012946 |
|---|---|
| Receipt number | R000015058 |
| Scientific Title | Quantitative verification of three PCA devices |
| Date of disclosure of the study information | 2014/01/27 |
| Last modified on | 2014/01/24 17:13:47 |
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Basic information
Public title
Quantitative verification of three PCA devices
Acronym
Quantitative verification of three PCA devices
Scientific Title
Quantitative verification of three PCA devices
Scientific Title:Acronym
Quantitative verification of three PCA devices
Region
| Japan |
Condition
Condition
Volunteer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify quantitatively that the three PCA devices can be operated exactly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Infusion rate; a percentage of the defined amount of each PCA devices
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Volunteers(age > 60 years) manipulate three PCA devices
Interventions/Control_2
Nurses with an experience of manipulating PCA device manipulate three PCA devices
Interventions/Control_3
Nurses without an experience of manipulating PCA device manipulates three PCA devices
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
age > 60 years
Nurses with/without an experience of manipulating PCA device
Key exclusion criteria
Finger movement disorder (Cerebral infarction, rheumatoid arthritis)
Cognitive dysfunction
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Tadokoro |
Organization
Okinawa Prefectural Miyako Hospital
Division name
Department of Anesthesia
Zip code
Address
427-1, Hirara Shimozato, Miyakojima-shi, Okinawa, 906-0013, Japan
TEL
08034237522
rover2727@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tadokoro |
Organization
Okinawa Prefectural Miyako Hospital
Division name
Department of Anesthesia
Zip code
Address
427-1, Hirara Shimozato, Miyakojima-shi, Okinawa, 906-0013, Japan
TEL
08034237522
Homepage URL
rover2727@yahoo.co.jp
Sponsor or person
Institute
Okinawa Prefectural Miyako Hospital
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
| 2014 | Year | 01 | Month | 27 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 24 | Day |
Last modified on
| 2014 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015058
