UMIN-CTR Clinical Trial

Basic information
Public title	Pediatric Alarm Study For Physiologic Monitoring in General Ward
Acronym	Ped. Alarm study (PEDAL study)
Scientific Title	Pediatric Alarm Study For Physiologic Monitoring in General Ward
Scientific Title:Acronym	Ped. Alarm study (PEDAL study)
Region	Japan

Condition
Condition	Patients with ECG or SpO2 monitor , hospitalized in pediatric general ward
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. To characterize how monitor alarms occurs and how we treat them 2. To evaluate relation with patients' condition and type or frequency of alarms 3. To evaluate influence on medical staffs' awareness about monitor alarms
Basic objectives2	Others
Basic objectives -Others	Observation
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ratio of alarms which require therapeutic nursing care or doctors' intervention to total alarms
Key secondary outcomes	> The frequency of alarms > The frequency of alarms by type > The ratio of patients who required monitor again after releasing monitor. > The ratio of patients who required emergency care (emergency call, transferring to PICU) > The number of days requiring monitoring > The nuber of days wearing monitor the stress with alarms and quality to intervention to alarm in medical staff

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ECG and/or SpO2 monitor which connected to central monitor
Key exclusion criteria	Patients who researchers judge are inappropriate Patients who refuse to enroll this study
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Akiko Middle name Last name Kinumaki
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Department of General Pediatrics
Zip code	183-8561
Address	183-8561 2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL	042-300-5111
Email	kinumaki-tky@umin.ac.jp

Public contact
Name of contact person	1st name Shogo Middle name Last name Akahoshi
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Department of General Pediatrics
Zip code	183-8561
Address	183-8561 2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL	042-300-5111
Homepage URL
Email	shougo_akahoshi@tmhp.jp

Sponsor
Institute	Department of General Pediatrics, Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Metropolitan Children's Medical Center
Address	2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
Tel	042-300-5111
Email	shougo_akahoshi@tmhp.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	2018 Year 08 Month 12 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	2018 Year 06 Month 02 Day
Date of IRB	2018 Year 06 Month 11 Day
Anticipated trial start date	2018 Year 07 Month 09 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2018 Year 08 Month 12 Day
Last modified on	2019 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037770