UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045579 |
|---|---|
| Receipt number | R000052039 |
| Scientific Title | Assessments of perioperative respiratory pattern with non-contact vital sign monitor in children undergoing minor surgery: Exploratory observational study. |
| Date of disclosure of the study information | 2021/09/29 |
| Last modified on | 2021/09/27 20:34:29 |
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Basic information
Public title
Assessments of perioperative respiratory pattern with non-contact vital sign monitor in children undergoing minor surgery: Exploratory observational study.
Acronym
Assessments of perioperative respiratory pattern with non-contact vital sign monitor in children undergoing surgery.
Scientific Title
Assessments of perioperative respiratory pattern with non-contact vital sign monitor in children undergoing minor surgery: Exploratory observational study.
Scientific Title:Acronym
Assessments of perioperative respiratory pattern with non-contact vital sign monitor in children undergoing surgery.
Region
| Japan |
Condition
Condition
Minor surgery for children including inguinal hernia, nevus of Ota, etc.
Classification by specialty
| Surgery in general | Pediatrics | Anesthesiology |
| Operative medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Use a non-contact biometric monitor to test the hypothesis that a temporary decrease in respiratory rate is observed at rest in the hospital room after surgery, but recovers rapidly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detect that the resting breathing rate immediately after surgery differs from 2 hours after surgery by 3-5 breaths / minute.
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 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA-PS1 and 2 pediatric patients undergoing scheduled minor surgery under general anesthesia at Chiba University Hospital.
Key exclusion criteria
Emergency surgery, scheduled surgery for 3 hours or more, consent is not obtained.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hateruma |
Organization
Chiba University Hospital
Division name
Department of Anesthesia, Pain and Palliative Medicine
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171(6771)
aeua.yuki@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hateruma |
Organization
Chiba University Hospital
Division name
Department of Anesthesia, Pain and Palliative Medicine
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171(6771)
Homepage URL
aeua.yuki@gmail.com
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-222-7171(extension 6771)
aeua.yuki@gmail.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
| 2021 | Year | 09 | Month | 29 | 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 | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Currently, there are no non-contact, continuous respiration measuring devices in children. Chiba University is developing a device that continuously measures biological information signals including respiratory from the signals of load cells installed under the legs of the bed in a non-invasive, unrestrained state without restricting the activity of the subject. In this study, we test the hypothesis that "a temporary decrease in respiratory rate (primary endpoint) is observed at rest in the hospital room after surgery, but it recovers quickly" by the sensor measurement.
Management information
Registered date
| 2021 | Year | 09 | Month | 27 | Day |
Last modified on
| 2021 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052039
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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