UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033727 |
|---|---|
| Receipt number | R000037770 |
| Scientific Title | Pediatric Alarm Study For Physiologic Monitoring in General Ward |
| Date of disclosure of the study information | 2018/08/12 |
| Last modified on | 2019/08/15 22:18:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shougo_akahoshi@tmhp.jp
Sponsor or person
Institute
Department of General Pediatrics,
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037770
