UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019327 |
|---|---|
| Receipt number | R000022190 |
| Scientific Title | Study in utility of nerve conduction Device for prediction of perioperative hemodynamic instability of diabetic patients |
| Date of disclosure of the study information | 2015/10/15 |
| Last modified on | 2015/10/15 17:25:08 |
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Basic information
Public title
Study in utility of nerve conduction Device for prediction of perioperative hemodynamic instability of diabetic patients
Acronym
Study in utility of nerve conduction Device for prediction of perioperative hemodynamic instability of diabetic patients
Scientific Title
Study in utility of nerve conduction Device for prediction of perioperative hemodynamic instability of diabetic patients
Scientific Title:Acronym
Study in utility of nerve conduction Device for prediction of perioperative hemodynamic instability of diabetic patients
Region
| Japan |
Condition
Condition
Perioperative diabetic patients
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of nerve conduction device for prediction of perioperative hemodynamic instability and the degree ofautonomic neuropathy in diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Preoperative measured value of nerve conduction devide
2) Perioperative hemodynamic parameters
3) Parameters of heart rate viability
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The type 2 diabetic and non-diabetic (as control) adult patients who are given surgery under general anesthesia
Key exclusion criteria
ASA PS >3
Emergency cases
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Nakayama |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology and Intensive
Zip code
Address
Kajiicho465 Kamigyo-Ku, Kyoto, Japan
TEL
0752515633
na-yoshi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Nakayama |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology and Intensive
Zip code
Address
Kajiicho465 Kamigyo-Ku, Kyoto, Japan
TEL
0752515633
Homepage URL
na-yoshi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants in aid for scientific research (Japan society for the promotion of scientific research)
Organization
Division
Category of Funding Organization
Other
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 | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study(cohort study)
<Participant recruitment>
All patients, who are matched to the inclusion ctiteria, are scheduled surgery under general anesthesia in operating room of Kyoto prefectural university of medicine between Dec.1th 2015 and Dec. 1th 2017
<Measurements>
Preoperative nerve conduction study (Amplitude, conduction velocity)
Perioperative heart rate variability(Frequency of HRV, LF, HF, LF/HF ratio, etc)
Perioperative hemodynamic parameters(BP, HR, SVI, SVV, etc)
Severity of diabetes
Management information
Registered date
| 2015 | Year | 10 | Month | 13 | Day |
Last modified on
| 2015 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022190
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
