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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041020
Receipt No. 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 2020/07/07

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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
Email 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
Email makoto.01.hasegawa@med.toho-u.ac.jp

Sponsor
Institute Toho university
Institute
Department

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
Address 6-11-1 omorinisi otaku Tokyo
Tel 03-3762-4151
Email makoto.01.hasegawa@med.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
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 Open public recruiting
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
2020 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.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


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