UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032587 |
|---|---|
| Receipt number | R000028787 |
| Scientific Title | Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery |
| Date of disclosure of the study information | 2018/05/14 |
| Last modified on | 2018/05/14 15:55:45 |
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Basic information
Public title
Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery
Acronym
Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery
Scientific Title
Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery
Scientific Title:Acronym
Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery
Region
| Japan |
Condition
Condition
Patients who underwent cardiovascular surgery
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare blood pressure measured by Clearsight system with intra-arterial pressure during anesthetic induction in patients undergoing cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interchangeability of blood pressure measured by Clearsight system
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients in whom noninvasive arterial pressure was measured by ClearSightSystem and invasive radial arterial pressure was measured simultaneously during anesthetic induction of cardiovascular surgery.
Key exclusion criteria
no
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tanioku tadashi |
Organization
Wakayama medical university
Division name
department of anesthesiology
Zip code
Address
811-1 kimiidera wakayama-city
TEL
073-447-2300
ttanioku@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | tanioku tadashi |
Organization
Wakayama medical university
Division name
department of anesthesiology
Zip code
Address
811-1 kimiidera wakayama-city
TEL
073-447-2300
Homepage URL
ttanioku@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university department of anesthesiology
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
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
| 2018 | Year | 05 | Month | 14 | 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 | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective study included patients who underwent elective cardiovascular surgerybetween november 2016 and march 2017 in our hospital. We analyzed data for 18 patients in whom noninvasive arterial pressure was measured by Clearsight System and invasive radial arterial pressure was measured simultaneously during anesthetic induction.
Management information
Registered date
| 2018 | Year | 05 | Month | 14 | Day |
Last modified on
| 2018 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028787
