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

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 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


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

Value
https://center6.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