UMIN-CTR Clinical Trial

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
Institute	Tokyo Medical University
Institute
Department

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
URL(English)	https://upload.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

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