UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041020 |
|---|---|
| Receipt number | R000045621 |
| Scientific Title | Relationship between PWTT in ears, fingers and toes using estimated continuous cardiac output |
| Date of disclosure of the study information | 2020/07/07 |
| Last modified on | 2021/07/09 07:24:57 |
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Basic information
Public title
Relationship between PWTT in ears, fingers and toes using estimated continuous cardiac output
Acronym
Relationship between PWTT in ears, fingers and toes using estimated continuous cardiac output
Scientific Title
Relationship between PWTT in ears, fingers and toes using estimated continuous cardiac output
Scientific Title:Acronym
Relationship between PWTT in ears, fingers and toes using estimated continuous cardiac output
Region
| Japan |
Condition
Condition
General anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the correlation between PWTT and esCCO depending on the measurement site.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PWTT value, esCCO value
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
SpO2 monitor attached to finder
Interventions/Control_2
SpO2 monitor attached to Toe
Interventions/Control_3
SpO2 monitor attached to ear
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient of ASA-PS 1-3
Key exclusion criteria
Patient of arrhythmia and pacing
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hasegawa |
Organization
Toho university omori medical center
Division name
Anesthesiology
Zip code
1430015
Address
6-11-1 omorinisi otaku Tokyo
TEL
03-3762-4151
makoto.01.hasegawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Hasegawa |
Organization
Toho university omori medical center
Division name
Anesthesiology
Zip code
1430015
Address
6-11-1 omorinisi otaku Tokyo
TEL
03-3762-4151
Homepage URL
makoto.01.hasegawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
Toho university omori medical center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho university Omori Medical Center Ethics Committee Bureau
Address
6-11-1,Omorinisi,Ota-ku,Tokyo
Tel
03-3762-4151
omori.rinri@ext.toho-u.ac.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
| 2020 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
https://mylibrary.toho-u.ac.jp/webopac/bdyview.do?bodyid=TD19869960&elmid=Body&fname=td19869960_cove
Publication of results
Published
Result
URL related to results and publications
https://mylibrary.toho-u.ac.jp/webopac/bdyview.do?bodyid=TD19869960&elmid=Body&fname=td19869960_cove
Number of participants that the trial has enrolled
31
Results
SVI and CI based on PWTT measured on the toes were shown to be highly correlated and followable with the data measured on the fingers.
Results date posted
| 2021 | Year | 07 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
Patients with ASA-PS1 or 2 undergoing otolaryngology under general anesthesia
Participant flow
Before undergoing surgery, he explained individually and issued a written consent.
Adverse events
none
Outcome measures
PWTT,esSVI,esCCI,esSVV
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 07 | Day |
Last modified on
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
