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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040626
Receipt No. 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

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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
Email 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
Email mby0813@gmail.com

Sponsor
Institute UBE Kohsan Central Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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