UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery
Title of the study (Brief title)	Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery
Region	Japan

Condition
Condition	Patients who underwent cardiovascular surgery
Classification by specialty	Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare blood pressure measured by Clearsight system with intra-arterial pressure during anesthetic induction in patients undergoing cardiovascular surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Interchangeability of blood pressure measured by Clearsight system
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients in whom noninvasive arterial pressure was measured by ClearSightSystem and invasive radial arterial pressure was measured simultaneously during anesthetic induction of cardiovascular surgery.
Key exclusion criteria	no
Target sample size	20

Research contact person
Name of lead principal investigator	tanioku tadashi
Organization	Wakayama medical university
Division name	department of anesthesiology
Address	811-1 kimiidera wakayama-city
TEL	073-447-2300
Email	ttanioku@wakayama-med.ac.jp

Public contact
Name of contact person	tanioku tadashi
Organization	Wakayama medical university
Division name	department of anesthesiology
Address	811-1 kimiidera wakayama-city
TEL	073-447-2300
Homepage URL
Email	ttanioku@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical university department of anesthesiology
Institute
Department

Funding Source
Organization	Wakayama medical university department of anesthesiology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 05 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 08 Day
Anticipated trial start date	2017 Year 05 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This retrospective study included patients who underwent elective cardiovascular surgerybetween november 2016 and march 2017 in our hospital. We analyzed data for 18 patients in whom noninvasive arterial pressure was measured by Clearsight System and invasive radial arterial pressure was measured simultaneously during anesthetic induction.

Management information
Registered date	2018 Year 05 Month 14 Day
Last modified on	2018 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028787