UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054883 |
|---|---|
| Receipt number | R000062708 |
| Scientific Title | Comparative study of the 5breaths-10beats method and 60 seconds measurement in measuring respiratory rate and heart rate |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2026/01/05 00:15:12 |
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Basic information
Public title
Comparative study of the 5breaths-10beats method and 60 seconds measurement in measuring respiratory rate and heart rate
Acronym
Comparative study of the 5breaths-10beats method
Scientific Title
Comparative study of the 5breaths-10beats method and 60 seconds measurement in measuring respiratory rate and heart rate
Scientific Title:Acronym
Comparative study of the 5breaths-10beats method
Region
| Japan |
Condition
Condition
acute disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the accuracy of the 5 breaths-10beats method and that of 60 seconds measurement in measuring respiratory rate and heart rate, and to clarify the difference in accuracy of 5 breaths-10beats method according to age groups and disease groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in respiratory rate and heart rate between 5breaths-10beats method and 60 seconds measurement in subgroup stratified by age in months.
Key secondary outcomes
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
| 1 | days-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following.
1. To admit the Department of General Pediatrics in Tokyo Metropolitan Children's Medical Center during the research enrollment period.
2. Under 15 years of age at the time of admission.
3. To give free and voluntary oral consent based on a thorough understanding of the subject matter after having been fully informed of the purpose of participation.
Key exclusion criteria
Those who meet at least one of the following.
1. Those under mechanical ventilation.
2. Those with a history of arrythmia.
3. Those with desperate breathing, Cheyne-Stokes respiration, Kussmaul respiration or apnea.
4. Those who are hospitalized again during the study period.
5. Those who are deemed inappropriate by the principal investigator or subinvestigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Shoji |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of General Pediatrics
Zip code
183-8561
Address
2- 8-29 Musashidai, Fuchu, Tokyo
TEL
042-300-5111
takashi_shoji@tmhp.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Shoji |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of General Pediatrics
Zip code
183-8561
Address
2- 8-29 Musashidai, Fuchu, Tokyo
TEL
042-300-5111
Homepage URL
takashi_shoji@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Children's Medical Center
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, Tokyo
Tel
042-300-5111
takashi_shoji@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
| 2024 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to compare the 5breaths-10beats method with 60 seconds measurement of respiratory rate and heart rate and to identify age groups and disease groups for which the accuracy of the 5breaths-10beats method can be guaranteed. If these results indicate that the 5breaths-10beats method is simpler and more accurate, it may be possible to detect abnormal respiratory rate earlier than before.
Management information
Registered date
| 2024 | Year | 07 | Month | 04 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062708
