UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022001 |
|---|---|
| Receipt number | 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 15:26:44 |
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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
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
tomamu16@hotmail.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025353
