UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019165 |
|---|---|
| Receipt number | R000022158 |
| Scientific Title | Can a new non-contact electro cardiogram device detect the arrythmia in the post-cardiacsurgery patients; prospective clinical trial in an intensive care unit. |
| Date of disclosure of the study information | 2015/09/30 |
| Last modified on | 2015/09/30 14:15:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Can a new non-contact electro cardiogram device detect the arrythmia in the post-cardiacsurgery patients; prospective clinical trial in an intensive care unit.
Acronym
Can a new non-contact ECG device detect the arrythmia ; prospective clinical trial.
Scientific Title
Can a new non-contact electro cardiogram device detect the arrythmia in the post-cardiacsurgery patients; prospective clinical trial in an intensive care unit.
Scientific Title:Acronym
Can a new non-contact ECG device detect the arrythmia ; prospective clinical trial.
Region
| Japan |
Condition
Condition
patients who are receaved the cardiovascular surgery
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare the new ECG device (non-contact type) with a conventional ECG in a ditection of arrhythmia.
We will select the patient who are given the cardiovascular surgery.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of arrhythmia in 24 hours
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
non-contact electro cardiogram (24hors after surgery)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who are given the cardio vasculer surgery
Key exclusion criteria
1)skin weekness
2)non-stable patients due to surgical or tecnical issue
(ex. patiens on ECMO or patients with IABP )
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kota Kamizato |
Organization
Fucuty of Medicine, Uneversity of the Ryukyus
Division name
Anesthesiology
Zip code
Address
207 Uehara Nishihara-cho OKINAWA, Japan
TEL
+81-98-895-3331
kotakamizato@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kota Kamizato |
Organization
Fucuty of Medicine, Uneversity of the Ryukyus
Division name
Anesthesiology
Zip code
Address
207 Uehara Nishihara-cho OKINAWA, Japan
TEL
+81-98-895-3331
Homepage URL
kotakamizato@mac.com
Sponsor or person
Institute
Department of Anesthesiology, Fucuty of Medicine, Uneversity of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Fucuty of Medicine, Uneversity of the Ryukyus
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
| 2015 | Year | 09 | Month | 30 | 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
| 2015 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2015 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022158
