UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040000
Receipt number R000043421
Scientific Title Prediction of level of consciousness by pupilometer in patients with impaired consciousness brought to emergency and critical care center
Date of disclosure of the study information 2020/04/30
Last modified on 2020/05/07 21:30:48

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Basic information

Public title

Prediction of level of consciousness by pupilometer in patients with impaired consciousness brought to emergency and critical care center

Acronym

Prediction of level of consciousness by pupilometer in patients with impaired consciousness brought to emergency and critical care center

Scientific Title

Prediction of level of consciousness by pupilometer in patients with impaired consciousness brought to emergency and critical care center

Scientific Title:Acronym

Prediction of level of consciousness by pupilometer in patients with impaired consciousness brought to emergency and critical care center

Region

Japan


Condition

Condition

disturbance of consciousness

Classification by specialty

Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To predict the neurological prognosis of patients with disturbance of consciousness transferred to emergency center by a pupillometer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glasgow coma scale at discharge or changing hospital

Key secondary outcomes



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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients over 16 years old, patients with informed consent, patients under Glasgow coma scale 8

Key exclusion criteria

Patients who have stayed in the emergency center within 48 hours, patients over GCS 8, patients after cardiac arrest, patients whose pupils cannot be observed

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yosuke
Middle name
Last name Minami

Organization

Tokyo Medical University Hospital

Division name

Emergency and Critical Care Center

Zip code

1600023

Address

Nishisinjuku6,Shinjuku-ku,Tokyo 160-0023 Japan

TEL

0333426111

Email

ymngufdream@gmail.com


Public contact

Name of contact person

1st name Yosuke
Middle name
Last name Minami

Organization

Tokyo Medical University

Division name

Emergency and Critical Care Center

Zip code

1600023

Address

Nishisinjuku6,Shinjuku-ku,Tokyo 160-0023 Japan

TEL

0333426111

Homepage URL


Email

ymngufdream@gmail.com


Sponsor or person

Institute

Tokyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical University Hospital

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

Tokyo Medical University Hospital

Address

Nishisinjuku6,Shinjuku-ku,Tokyo 160-0023 Japan

Tel

0333426111

Email

ymngufdream@gmail.com


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

2020 Year 04 Month 30 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

35

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

2017 Year 10 Month 31 Day

Date of IRB

2020 Year 03 Month 28 Day

Anticipated trial start date

2017 Year 10 Month 31 Day

Last follow-up date

2020 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 05 Month 31 Day


Other

Other related information

From the patient's medical records, we will pick up the pupil findings immediately after and 48 hours after arrival at the critical care center and the level of consciousness at discharge.This is an observational study.


Management information

Registered date

2020 Year 03 Month 31 Day

Last modified on

2020 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043421


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name