UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	rikizo.kogawa@med.toho-u.ac.jp

Sponsor
Institute	Toho University.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031118