UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038365 |
|---|---|
| Receipt number | R000043725 |
| Scientific Title | The predictive ability of the pulse oximetry-derived indexes for hypotension after spinal anesthesia for cesarean section: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2019/11/15 |
| Last modified on | 2022/10/04 00:35:38 |
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Basic information
Public title
The predictive ability of the pulse oximetry-derived indexes for hypotension after spinal anesthesia for cesarean section: A systematic review and meta-analysis
Acronym
The predictive ability of the pulse oximetry-derived indexes for hypotension after spinal anesthesia for cesarean section: A systematic review and meta-analysis
Scientific Title
The predictive ability of the pulse oximetry-derived indexes for hypotension after spinal anesthesia for cesarean section: A systematic review and meta-analysis
Scientific Title:Acronym
The predictive ability of the pulse oximetry-derived indexes for hypotension after spinal anesthesia for cesarean section: A systematic review and meta-analysis
Region
| Japan |
Condition
Condition
patients underwent cesarean section
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the predictive ability of these pulse oximetry-derived indexes (PI and PVI) for hypotension after spinal anesthesia for cesarean section.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hypotension
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
We included studies meeting the following criteria: enrolled patients underwent cesarean section; evaluated the PI or PVI for the prediction of hypotension after spinal anesthesia for cesarean section.
Key exclusion criteria
We excluded case reports, case series, animal studies.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Mihara |
Organization
Yokohama City University Hospital
Division name
Dept. Anesthesia
Zip code
236-0004
Address
Yokohama
TEL
07065586991
miharaxxxtotoro@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | Mihara |
| Last name | Mihara |
Organization
Yokohama City University Hospital
Division name
Dept. Anesthesia
Zip code
236-0004
Address
Yokohama
TEL
07065586991
Homepage URL
miharaxxxtotoro@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
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
NA
Address
NA
Tel
NA
Na
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
| 2019 | Year | 11 | Month | 15 | 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
0
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
Terminated
Date of protocol fixation
| 2019 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study protocol is attached in this pre-registration or can be seen at http://www-user.yokohama-cu.ac.jp/~masuika/protocol/
This study is a systematic review and meta-analysis.We follow the recommendations of the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines for diagnostic test accuracy and the Cochrane handbook for diagnostic test accuracy.
MEDLINE, Embase, Web of Science, The Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews will be searched; the reference lists of the retrieved full articles will be also searched. We will conduct further surveillance searches using the related articles feature. In addition, we will search the following pre-registration sites: the Clinicaltrial.gov, the European Union Clinical Trials Register (EU-CTR), the WHO International Clinical Trials Registry Platform (ICTRP), and the University Hospital Medical Information Network Clinical Trials Registry (UMIN).
Management information
Registered date
| 2019 | Year | 10 | Month | 23 | Day |
Last modified on
| 2022 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043725
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/11/16 | Study Protocol PI hypotension_for UMIN registration.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
