UMIN-CTR Clinical Trial

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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