UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032587
Receipt number R000028787
Scientific Title Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery
Date of disclosure of the study information 2018/05/14
Last modified on 2018/05/14 15:55:45

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Basic information

Public title

Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery

Acronym

Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery

Scientific Title

Validation of Clearsight system during anesthetic induction in patients undergoing cardiovascular surgery

Scientific Title:Acronym

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

1st name
Middle name
Last name tanioku tadashi

Organization

Wakayama medical university

Division name

department of anesthesiology

Zip code


Address

811-1 kimiidera wakayama-city

TEL

073-447-2300

Email

ttanioku@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name tanioku tadashi

Organization

Wakayama medical university

Division name

department of anesthesiology

Zip code


Address

811-1 kimiidera wakayama-city

TEL

073-447-2300

Homepage URL


Email

ttanioku@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama medical university department of anesthesiology

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2017 Year 05 Month 08 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028787


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name