UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015047 |
|---|---|
| Receipt number | R000017381 |
| Scientific Title | Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy. |
| Date of disclosure of the study information | 2014/09/16 |
| Last modified on | 2017/05/06 05:25:45 |
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Basic information
Public title
Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy.
Acronym
Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy.
Scientific Title
Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy.
Scientific Title:Acronym
Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy.
Region
| Japan |
Condition
Condition
Patients who are undergoing modified electroconvulsive therapy in Hamamatsu University School of Medicine
Classification by specialty
| Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the hemodynamic change throughout the period of modified electroconvulsive therapy not only one-time but also change over the time.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
HR,BP,CO,CI,SVV,SVR,SVRI,etc.(Indices that can be obtained by AESCULON.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
using Electrical Cardiometry (AESCULON®)
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients over 18 years old who underging modified electroconvulsive therapy
Key exclusion criteria
Patients whose skin attaching electrodes has trouble
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuya Kawashima |
Organization
Hamamatsu University Hospital
Division name
Department of Anesthesiology and Intensive Care
Zip code
Address
1-20-1, Handayama, Hamamatsu-shi, Shizuoka-ken
TEL
053-435-2111
yuyak@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MORISHITA Kaho |
Organization
Hamamatsu University Hospital
Division name
Department of Anesthesiology and Intensive Care
Zip code
Address
1-20-1, Handayama, Hamamatsu-shi, Shizuoka-ken
TEL
053-435-2111
Homepage URL
ryuu-ham@umin.ac.jp
Sponsor or person
Institute
Hamamatsu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University Hospital
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
浜松医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 16 | 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
| 2014 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 03 | Day |
Last modified on
| 2017 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017381
