UMIN-CTR Clinical Trial

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
Email	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
Email	hatachi@mch.pref.osaka.jp

Sponsor
Institute	Osaka Women's and Children's Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052488