UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046203 |
|---|---|
| Receipt number | R000052488 |
| Scientific Title | Continuous monitoring of analgesia and sedation using wearable device with motion sensors in a pediatric intensive care unit |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2021/11/26 20:09:00 |
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Basic information
Public title
Continuous monitoring of analgesia and sedation using wearable device with motion sensors in a pediatric intensive care unit
Acronym
Continuous monitoring of analgesia and sedation using wearable device with motion sensors in a pediatric intensive care unit
Scientific Title
Continuous monitoring of analgesia and sedation using wearable device with motion sensors in a pediatric intensive care unit
Scientific Title:Acronym
Continuous monitoring of analgesia and sedation using wearable device with motion sensors in a pediatric intensive care unit
Region
| Japan |
Condition
Condition
Childern in a pediatric intensive care unit
Classification by specialty
| Intensive care medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the usefulness of continuous monitoring of analgesia and sedation using wearable device with motion sensors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Correlation between body motion data such as frequency, duration, and intensity of body movements assessed by accelerometers and the SBS/RASS analgesic sedation scale assessed by observers.
Key secondary outcomes
(2) The incidence of discomfort, restlessness, or inability to continue wearing the wearable device, and the adverse events such as dermatitis.
(3) Association between the patient's restlessness, dangerous behaviors, and asynchronization with the mechanical ventilation observed by medical staff and inappropriate sedation state based on body motion data.
(4) Correlation between analgesic sedation evaluation using SBS/RASS analgesic sedation scale and body motion data with image information such as eye opening and crying.
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
Wearable 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
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children in pediatric intensive care unit
Key exclusion criteria
Exclude patients on muscle relaxants, with tetraplegia, with restrainer, with severe contractures, and with difficulty in wearing a wearable device, who have difficulty in assessing body movements. Patients with severe mental retardation who are difficult to assess for analgesia and sedation by SBS/RASS should also be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hatachi |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Intensive Care Medicine
Zip code
594-1101
Address
Murodo-cho 840, Izumi-City, Osaka, 594-1101 Japan
TEL
0725-56-1220
hatachi@mch.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hatachi |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Intensive Care Medicine
Zip code
594-1101
Address
Murodo-cho 840, Izumi-City, Osaka, 594-1101 Japan
TEL
0725-56-1220
Homepage URL
hatachi@mch.pref.osaka.jp
Sponsor or person
Institute
Osaka Women's and Children's 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
Osaka Women's and Children's Hospital
Address
Murodo-cho 840, Izumi-City, Osaka, 594-1101 Japan
Tel
0725-56-1220
hatachi@mch.pref.osaka.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
大阪母子医療センター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 26 | Day |
Last modified on
| 2021 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052488
| 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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| Registered date | File name |
