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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027385
Receipt No. R000031383
Scientific Title Comparison of iNIBP, linear inflation non-invasive blood pressure measurement, and conventional deflation NIBP in detecting hypotension during Caesarean section
Date of disclosure of the study information 2017/05/18
Last modified on 2018/04/29

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Basic information
Public title Comparison of iNIBP, linear inflation non-invasive blood pressure measurement, and conventional deflation NIBP in detecting hypotension during Caesarean section
Acronym Comparion of iNIBP and dNIBP during Caesarean section
Scientific Title Comparison of iNIBP, linear inflation non-invasive blood pressure measurement, and conventional deflation NIBP in detecting hypotension during Caesarean section
Scientific Title:Acronym 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
1st name
Middle name
Last name Shingo Irikoma
Organization Seirei hamamatsu General Hospital
Division name Depertment of Anesthesiology
Zip code
Address 12-2-2 Sumiyoshi, Hamamatsu City, Shizuoka
TEL 053-474-2222
Email s.irikoma@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Irikoma
Organization Seirei Hamamatsu General Hospital
Division name Depertment of Anesthesiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 06 Month 04 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000031383

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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