UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027154 |
|---|---|
| Receipt number | R000031118 |
| Scientific Title | Hemodynamic assessment in cesarean delivery using ClearSight system, non-invasive caridiac output monitoring. |
| Date of disclosure of the study information | 2017/04/27 |
| Last modified on | 2019/10/29 09:56:42 |
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Basic information
Public title
Hemodynamic assessment in cesarean delivery using ClearSight system, non-invasive caridiac output monitoring.
Acronym
Hemodynamic assessment by ClearSight system in cesarean delivery.
Scientific Title
Hemodynamic assessment in cesarean delivery using ClearSight system, non-invasive caridiac output monitoring.
Scientific Title:Acronym
Hemodynamic assessment by ClearSight system in cesarean delivery.
Region
| Japan |
Condition
Condition
Cesarean delivery for pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess hemodynamics and investigate suitable anesthetic management by ClearSight system, non-invasive hemodynamic monitoring during cesarean delivery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac output measured by ClearSight system and estimated Continuous Cardiac Output (esCCO) by Pulse Wave Transit Time (PWTT).
Key secondary outcomes
Another parameters measured by ClearSight system and Pulse Wave Transit Time (PWTT).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We will assess hemodynamic changes during cesarean delivery by using ClearSight system and measure esCCO (estimated Continuous Cordiac Output) calculated by PWTT (Pulse Wave Transit Time).
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients scheduled undergo elective cesarean delivery in study period.
Patients with verbal and written informed consent.
ASA risk score are 1/2.
Patients planned regional anesthesia.
Patients with a singleton.
Key exclusion criteria
Emergency cases.
Cases except for a singleton.
Cases whose fetus have any complications.
ASA risk score are above 3.
Patients planned general anesthesia.
Patients who have PIH (Pregnancy Induced Hypertension).
Patients underage.
Patients whose arm have ectreme contraction of vessels such as Raynaud disease.
Patients with internal shunt for dialysis.
Patients with allergy to drugs for study.
Cases expected bleeding or surgical time exceed normal cesarean section.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ochiai |
Organization
Omori Hospital, School of Medicine, Faculty of Medicine, Toho University.
Division name
Department of Anesthesiology
Zip code
143-8541
Address
6-11-1, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
ochiai-r@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Rikizo |
| Middle name | |
| Last name | Kogawa |
Organization
Omori Hospital, School of Medicine, Faculty of Medicine, Toho University.
Division name
Department of Anesthesiology
Zip code
143-8541
Address
6-11-1, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
rikizo.kogawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University.
Institute
Department
Personal name
Funding Source
Organization
none
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
Omori Hospital, School of Medicine, Faculty of Medicine, Toho University.
Address
6-11-1, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
Tel
03-3762-4151
rikizo.kogawa@med.toho-u.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
東邦大学医療センター大森病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 27 | 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 | 01 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 08 | 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
| 2017 | Year | 04 | Month | 27 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031118
| Research Plan | |
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| Registered date | File name |
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