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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018991
Receipt No. R000021965
Scientific Title Clinical evaluation of new algorithm about non-invasive blood pressure monitoring during perioperative period.
Date of disclosure of the study information 2015/09/14
Last modified on 2018/05/29

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Basic information
Public title Clinical evaluation of new algorithm about non-invasive blood pressure monitoring during perioperative period.
Acronym Improvement of non-invasive blood pressure monitoring.
Scientific Title Clinical evaluation of new algorithm about non-invasive blood pressure monitoring during perioperative period.
Scientific Title:Acronym Improvement of non-invasive blood pressure monitoring.
Region
Japan

Condition
Condition Adult patients undergoing major surgery under general anesthesia
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Obsterics and gynecology Orthopedics Urology
Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of precision and duration necessary to obtain data in newly developed non-invasive blood pressure monitor.
Basic objectives2 Others
Basic objectives -Others Clinical appraisal of patient monitor
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Precision compared to invasive arterial pressure during general anesthesia
Key secondary outcomes Difference of measurement time between new and conventional algorithm during general anesthesia

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who is indicated for invasive blood pressure monitoring
Patients undergoing curative surgery of malignancy.
Patients whose proposed surgery lasts more than 6 hours.
Patients whose predicted blood loss exceeds 1000ml
Key exclusion criteria Not applicable
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Kotake
Organization Toho University Ohashi Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-17-6, Ohashi, Meguro, Tokyo, Japan
TEL 03-3468-1251
Email ykotake@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshifumi Kotake
Organization Toho University Ohashi Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-17-6, Ohashi, Meguro, Tokyo, Japan
TEL 03-3468-1251
Homepage URL http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
Email ykotake@med.toho-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department

Funding Source
Organization Toho University Ohashi Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 東邦大学医療センター大橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 14 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 No longer recruiting
Date of protocol fixation
2015 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 15 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 04 Month 01 Day
Date trial data considered complete
2016 Year 04 Month 01 Day
Date analysis concluded
2016 Year 06 Month 30 Day

Other
Other related information The new algorithm has already been cleared of PMDA approval and has been on market. The new algorithm is characterized with shorter measurement time and lower inflation pressure. The purpose of this prospective, observational study is to confirm such advantages of new algorithm during perioperative period.

Management information
Registered date
2015 Year 09 Month 12 Day
Last modified on
2018 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021965

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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