UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021678
Receipt No. 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 (Ver. 7)

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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
Last 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
1st 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
Institute Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025001