UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049538 |
|---|---|
| Receipt number | R000056406 |
| Scientific Title | The verification of the new method for respiratory rate counting system with Spot-check-monitor |
| Date of disclosure of the study information | 2022/11/17 |
| Last modified on | 2024/05/19 20:07:42 |
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Basic information
Public title
The verification of the new method for respiratory rate counting system with Spot-check-monitor
Acronym
The verification of the new method for respiratory rate counting system with Spot-check-monitor
Scientific Title
The verification of the new method for respiratory rate counting system with Spot-check-monitor
Scientific Title:Acronym
The verification of the new method for respiratory rate counting system with Spot-check-monitor
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are going to verify the time and accuracy of counting respiratory rate, RR, and usability of this new system of Spot check monitor in clinical settings, attending our nurses.
Predicting deteriorating patients conditions, RR is one of the most important vital signs. However, there are few devices that can monitor RR easily as compared with other vital signs, such as heart rate, blood pressure, body temperature, and saturation of oxygen. Moreover, measuring RR needs nurses to watch for motions of the patient chest for more than 30 seconds or 60 seconds, it could be annoying in the clinical settings. Our research showed that only 50 percent about RR were documented in electrical chart systems.
On the one hand, our hospital introduced rapid response systems for patients safety with Spot check monitor, which can transfer documents of measured viral signs to the electrical charts and can show National Early Warning Scores, NEWS, of all patients with using Spot check monitor which were shown in the descending order in the electric charts. We use Spot check monitor for measuring the patients vital signs in our hospital and now the new version of Spot check monitor had had counting RR system. We are going to verify this new system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint:
With our new version of the vital sign monitoring system,
1, measuring time of respiratory rate (RR).
2, accuracy of measured RR.
Key secondary outcomes
Secondary endpoint:
Using questionnaires to confirm usability such as easiness of manipulation and so on.
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
| 24 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult staffs with no problem breathing.
Key exclusion criteria
None.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiso |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University
Division name
Anesthesiology and Intensive Care Medicine
Zip code
480-1195
Address
Nagakute
TEL
0561623311
fujiyossy@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Yoshida |
Organization
Aichi Medical University
Division name
Ethics Committee
Zip code
4801195
Address
Nagakute
TEL
05616623311
Homepage URL
aichi-med@esct.bvits.com
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding,
Department of Anesthesiology and Intensive Care
Aichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical university Ethics Committee
Address
1-1 Karimata Yazako, Nagakute, Aichi
Tel
0561623311
aichi-med@esct.bvits.com
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
| 2022 | Year | 11 | Month | 17 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056406
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
9
Results
we are analyzing now.
Results date posted
| 2024 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Now we are analyzing.
Participant flow
The participants were 9 people.
Adverse events
Non.
Outcome measures
Now we are analyzing.
Plan to share IPD
We are planning to register UMIN-ICDS.
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2022 | Year | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056406
