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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022001
Receipt No. R000025353
Scientific Title Evaluation of the usefulness of noninvasive monitoring device for seriously ill patients
Date of disclosure of the study information 2016/04/21
Last modified on 2017/08/02

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Basic information
Public title Evaluation of the usefulness of noninvasive monitoring device for seriously ill patients
Acronym Evaluation of the usefulness of noninvasive monitoring device
Scientific Title Evaluation of the usefulness of noninvasive monitoring device for seriously ill patients
Scientific Title:Acronym Evaluation of the usefulness of noninvasive monitoring device
Region
Japan

Condition
Condition critically ill patients
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to evaluate the equivalency between the measurements of the blood pressure to be provided by an arterial blood pressure line and the measurements of the blood pressure to be provided by a new idevice.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome is to evaluate the equivalency between the measurements of the blood pressure(systolic, diastolic, and mean blood pressure) to be provided by a new device and the measurements of the blood pressure to be provided by an arterial pressure line.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 I put on an examination device for 30 minutes and monitor measurements
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 Male and Female
Key inclusion criteria (1)The ICU/CCU admission patients, emergency outpatients and patients operated on by the general anesthesis that an arterial blood pressure line is detained as a part of the normal medical treatment act.
(2)The patient who understand an examination in response to explanation enough, and that I can get a document agreement by the free will of a patient.
Key exclusion criteria (1)The patient who puts on the IABP and the PCPS.
(2)The patient who is not suitable for the wearing of the device for a burn and other skin problems.
(3)The patient who receives an examination of MRI during an examination.
(4)The patient who receives an treatment of hyperbaric oxygen therapy during an examination
(5)The patient who has hypersensitivity to infrared rays and transmitted light.
(6)The patient whom it was judged not to be able to carry out an examination safely by a doctor.
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeto Oda
Organization Chiba University Hospital, Department of Emergency and Critical Care Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL 043-226-2341
Email odas@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Tomita
Organization Chiba University Hospital, Department of Emergency and Critical Care Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL 043-226-2341
Homepage URL
Email tomamu16@hotmail.co.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 04 Month 21 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 Completed
Date of protocol fixation
2016 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 20 Day
Last modified on
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025353

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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