UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030403 |
|---|---|
| Receipt number | R000034717 |
| Scientific Title | Study for changes of electrocardiogram (ECG) waveform of pediatric patients under anesthesia due to ECG filtering |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2018/06/16 12:21:28 |
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Basic information
Public title
Study for changes of electrocardiogram (ECG) waveform of pediatric patients under anesthesia due to ECG filtering
Acronym
Study for changes of electrocardiogram (ECG) waveform of pediatric patients
Scientific Title
Study for changes of electrocardiogram (ECG) waveform of pediatric patients under anesthesia due to ECG filtering
Scientific Title:Acronym
Study for changes of electrocardiogram (ECG) waveform of pediatric patients
Region
| Japan |
Condition
Condition
intraoral lesion
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on changes of electrocardiogram (ECG) waveform of pediatric patients under anesthesia due to ECG filtering
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The changes of R-wave height at the end of anesthetic induction, after 1h, 2h and 3h due to ECG filtering.
Key secondary outcomes
The changes of T-wave height and the ratio of height of R-wave and T-wave at the end of anesthetic induction, after 1h, 2h and 3h due to ECG filtering.
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
| 2 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients under 6 year-old undergoing oral treatment under general anesthesia.
Key exclusion criteria
Patients with heart disease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yokoyama |
Organization
kyushu university
Division name
dental anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6480
yokoyama@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Hirokawa |
Organization
kyushu university
Division name
dental anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6480
Homepage URL
hj8823@gmail.com
Sponsor or person
Institute
department of dental anesthesiology, kyushu university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 12 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 12 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 12 | Day |
Date analysis concluded
Other
Other related information
Study on changes of electrocardiogram (ECG) waveform of pediatric patients under anesthesia due to ECG filtering
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2018 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034717
