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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000038365
Receipt No. 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 2020/04/23

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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
Email 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
Email miharaxxxtotoro@yahoo.co.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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
Email 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
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 Suspended
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
2020 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
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.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


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