UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027385 |
|---|---|
| Receipt number | 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 14:51:55 |
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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
| Obstetrics 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
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
s.irikoma@gmail.com
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031383
