UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050243 |
|---|---|
| Receipt number | R000057217 |
| Scientific Title | A pilot study that evaluates the efficacy of the wireless device to detect a patient's self-extraction of an intravascular catheter or a nasogastric tube and informs a nurse or doctor in charge. |
| Date of disclosure of the study information | 2023/02/07 |
| Last modified on | 2023/02/06 14:15:50 |
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Basic information
Public title
A pilot study that evaluates the efficacy of the wireless device to detect a patient's self-extraction of an intravascular tube and informs a nurse or doctor in charge.
Acronym
A study that evaluates the efficacy of the device to detect a patient's self-extraction of an IV tube and informs a nurse or doctor.
Scientific Title
A pilot study that evaluates the efficacy of the wireless device to detect a patient's self-extraction of an intravascular catheter or a nasogastric tube and informs a nurse or doctor in charge.
Scientific Title:Acronym
A study that evaluates the efficacy of the device to detect a patient's self-extraction of an IV tube or a NG tube and informs a nurse or doctor.
Region
| Japan |
Condition
Condition
higher brain dysfunction
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce a patient's complications
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success in detection and prevention, failure of detection, incorrect detection, success in detection but failure in prevention
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To use a test device
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are 70 years or older, have altered mental status, dementia, a history of psychiatric diseases, a history of delirium, an extraction of an IV tube or nasogastric tube, or a possibility of extracting a tube.
Key exclusion criteria
In case a patient or his/her legal guardian does not consent to participating in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Miyamoto |
Organization
International University of Health and Welfare Atami Hospital
Division name
Department of Neurosurgery
Zip code
4130012
Address
13-1 Higashikaigancho Atami City, Shizuoka, Japan
TEL
0557819171
smiyamoto@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Miyamoto |
Organization
International University of Health and Welfare Atami Hospital
Division name
Department of Neurosurgery
Zip code
4130012
Address
13-1 Higashikaigancho Atami City, Shizuoka, Japan
TEL
0557819171
Homepage URL
shinyamiyamoto@hotmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self-funded
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
International University of Health and Welfare Atami Hospital
Address
13-1 Higashikaigancho Atami City, Shizuoka, Japan
Tel
0557819171
smiyamoto@iuhw.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 | 02 | Month | 07 | 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
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | 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 | 02 | Month | 06 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057217
