UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040626 |
|---|---|
| Receipt number | R000046366 |
| Scientific Title | Comparison of esCCO calibration before and after anesthesia introduction |
| Date of disclosure of the study information | 2020/06/03 |
| Last modified on | 2020/06/05 10:47:53 |
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Basic information
Public title
Comparison of esCCO calibration before and after anesthesia introduction
Acronym
Comparison of esCCO calibration before and after anesthesia introduction
Scientific Title
Comparison of esCCO calibration before and after anesthesia introduction
Scientific Title:Acronym
Comparison of esCCO calibration before and after anesthesia introduction
Region
| Japan |
Condition
Condition
Patients who undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Which timing should esCCO be calibrated before or after anesthesia induction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
esCCO measured before and afer anesthesia induction calibrated before anesthesia induction.
And esCCO calibrated after anesthesia induction.
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
Adult patients scheduled to undergo general anesthesia undergoing preoperative echocardiography
Key exclusion criteria
1) Patients who are recognized as "patients who have difficulty in anesthesia" defined in the medical treatment fee score table L008 in the preoperative consultation
2) Patients with the following findings of arrhythmia confirmed by preoperative consultation
i) Supraventricular rhythm irregularity such as atrial fibrillation, atrial flutter, sinus arrhythmia
ii) bigeminal or trigeminal pulse
iii) 2nd degree AV block, 3rd degree AV block
3) Patients who need pacing during surgery
4) Patients who need repositioning during surgery
5) Patients with cardiac tamponade
6) Patients who have undergone cardiopulmonary bypass surgery
7) Patients who have undergone artificial vascular replacement surgery
8) Patients undergoing emergency surgery
9) Patients who are judged to be inappropriate for this study by the investigator
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Hidaka |
Organization
UBE Kohsan Central Hospital
Division name
Department of Anesthesiology
Zip code
755-0151
Address
750 Nishikiwa, Ube-shi, Yamaguchi-ken
TEL
0836-51-9338
hidaka0709@gmail.com
Public contact
Name of contact person
| 1st name | yoshiyuki |
| Middle name | |
| Last name | Hidaka |
Organization
UBE Kohsan Central Hospital
Division name
Department of Anesthesiology
Zip code
755-0151
Address
750 Nishikiwa, Ube-shi, Yamaguchi-ken
TEL
0836-51-9338
Homepage URL
mby0813@gmail.com
Sponsor or person
Institute
UBE Kohsan Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
UBE Kohsan Central Hospital
Address
Department of Anesthesiology
Tel
0836-51-9338
mby0813@gmail.com
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 | 06 | Month | 03 | 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 | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 06 | Month | 02 | Day |
Last modified on
| 2020 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046366
| 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 |
