UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021654 |
|---|---|
| Receipt number | R000024971 |
| Scientific Title | Usefulness of the Clearsight system for hemodynamic management in patients undergoing cesarean delivery |
| Date of disclosure of the study information | 2016/03/28 |
| Last modified on | 2020/04/02 08:06:29 |
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Basic information
Public title
Usefulness of the Clearsight system for hemodynamic management in patients undergoing cesarean delivery
Acronym
The Clearsight system for cesarean delivery
Scientific Title
Usefulness of the Clearsight system for hemodynamic management in patients undergoing cesarean delivery
Scientific Title:Acronym
The Clearsight system for cesarean delivery
Region
| Japan |
Condition
Condition
Patients undergoing cesarean delivery under spinal anesthesia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether hemodynamic management using the Clearsight system can prevent the incidence of hypotension induced by spinal anesthesia for cesarean delivery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of hypotension after spinal anesthesia
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
Female
Key inclusion criteria
Patients undergoing cesarean delivery under spinal anesthesia
Key exclusion criteria
1) Non-reassuring fetal status
2) Systolic blood pressure <80mmHg
3) Arrhythmia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Suehiro |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
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 | |
| Middle name | |
| Last name | Koichi Suehiro |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
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
Address
Tel
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 | 28 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All subjects are divided into "Clearsight group" or "Non-Clearsight group". The incidence of hypotension will be compared between the two groups.
Management information
Registered date
| 2016 | Year | 03 | Month | 28 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024971
