UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021678
Receipt number R000025001
Scientific Title Usefulness of the Clearsight system for hemodynamic management in patients undergoing total knee arthroplasty
Date of disclosure of the study information 2016/03/30
Last modified on 2019/04/05 13:21:52

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Basic information

Public title

Usefulness of the Clearsight system for hemodynamic management in patients undergoing total knee arthroplasty

Acronym

The Clearsight system for total knee arthroplasty

Scientific Title

Usefulness of the Clearsight system for hemodynamic management in patients undergoing total knee arthroplasty

Scientific Title:Acronym

The Clearsight system for total knee arthroplasty

Region

Japan


Condition

Condition

Patients undergoing total knee arthroplasty under general anesthesia

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether hemodynamic management using the Clearsight system can induce the hemodynamic stability during general anesthesia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time duration with hemodynamic stability

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Hemodynamic management using the Clearsight system

Interventions/Control_2

Hemodynamic management without the Clearsight system

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

Patients undergoing total knee arthroplasty under general anesthesia

Key exclusion criteria

1) Patients with Arrhythmia
2) Patients with ejection fraction <50%
3) Patients with valvular disease

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Suehiro

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

545-8586

Address

1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan

TEL

06-6645-2186

Email

suehirokoichi@yahoo.co.jp


Public contact

Name of contact person

1st name Koichi
Middle name
Last name Suehiro

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

545-8586

Address

1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan

TEL

06-6645-2186

Homepage URL


Email

suehirokoichi@yahoo.co.jp


Sponsor or person

Institute

Department of Anesthesiology, Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Osaka City University Graduate School of Medicine

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

Ethics Committee of Osaka City University Graduate School of Medicine

Address

1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan

Tel

81-6-6646-6125

Email

ethics@med.osaka-cu.ac.jp


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

2016 Year 03 Month 30 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007%2Fs10877-018-0125-4

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007%2Fs10877-018-0125-4

Number of participants that the trial has enrolled

40

Results

We demonstrated that hemodynamic management using the continuous non-invasive BP monitoring can induce intra-anesthetic hemodynamic stability. The accuracy and trending ability of the continuous non-invasive BP monitoring for BP measurement was clinically acceptable, and led to intraoperative hemodynamic stability and a reduced incidence of intra-anesthetic hypotension and hypertension.

Results date posted

2019 Year 04 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients undergoing general anesthesia

Participant flow

Enrolled patients were divided into two groups: Control group managed by non-invasive blood pressure and CS group managed by non-invasive hemodynamic monitoring (ClearSight system).

Adverse events

None

Outcome measures

Incidence of intraoperative hypotension and hypertension

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 03 Month 01 Day

Date of IRB

2016 Year 03 Month 24 Day

Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 30 Day

Last modified on

2019 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025001


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name