UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of iNIBP, linear inflation non-invasive blood pressure measurement, and conventional deflation NIBP in detecting hypotension during Caesarean section
Title of the study (Brief title)	Comparion of iNIBP and dNIBP during Caesarean section
Region	Japan

Condition
Condition	Singleton planned caesarean section under the combined spinal-epidural anesthesia (CSEA) technique through a single puncture after 36 weeks gestation
Classification by specialty	Obsterics and gynecology Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate prospectively if iNIBP can detect maternal hypotension during caesarean section more quickly than dNIBP in the clinical setting.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The time to detect maternal hypotension after beginning of anesthesia(second)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	50 years-old >=
Gender	Female
Key inclusion criteria	Singleton planned caesarean section at single tertialy center under the combined spinal-epidural anesthesia (CSEA) technique through a single puncture after 36 weeks gestaion.
Key exclusion criteria	Preterm delivery < 36 weeks gestation, Caesarean secton under general anesthesia
Target sample size	100

Research contact person
Name of lead principal investigator	Shingo Irikoma
Organization	Seirei hamamatsu General Hospital
Division name	Depertment of Anesthesiology
Address	12-2-2 Sumiyoshi, Hamamatsu City, Shizuoka
TEL	053-474-2222
Email	s.irikoma@gmail.com

Public contact
Name of contact person	Shingo Irikoma
Organization	Seirei Hamamatsu General Hospital
Division name	Depertment of Anesthesiology
Address	12-2-2 Sumiyoshi, Hamamatsu City, Shizuoka
TEL	053-474-2222
Homepage URL
Email	s.irikoma@gmail.com

Sponsor
Institute	Seirei Hamamatsu General Hospital
Institute
Department

Funding Source
Organization	Nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 05 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 04 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	An iNIBP cuff was placed on the same arm as an intravenous line, and a dNIBP cuff was placed on the other arm. Because of left uterine displacement (about 10 degree) to prevent hypotension, we defined hypotension as systolic pressure of 107 mmHg or less on the left arm which is about 10 cm lower and pressure of 92 mmHg or less on the right arm which is about 10 cm higher. We examined which detect hypotension more quickly in the clinical setting. A two-tailed Z test was performed to statistically analyze the difference between iNIBP and dNIBP measurement results.

Management information
Registered date	2017 Year 05 Month 18 Day
Last modified on	2018 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031383