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
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
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
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
