UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the usefulness of noninvasive monitoring device for seriously ill patients
Title of the study (Brief title)	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	Shigeto Oda
Organization	Chiba University Hospital, Department of Emergency and Critical Care Medicine
Division name	Department of Emergency and Critical Care Medicine
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	Keisuke Tomita
Organization	Chiba University Hospital, Department of Emergency and Critical Care Medicine
Division name	Department of Emergency and Critical Care Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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