UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058237 |
|---|---|
| Receipt number | R000066201 |
| Scientific Title | Evaluation of the usefulness of an automatic pupil measurement device for diagnosing consciousness disorders in patients with acute drug poisoning: A single-center prospective observational study |
| Date of disclosure of the study information | 2025/06/21 |
| Last modified on | 2025/06/20 13:43:38 |
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Basic information
Public title
A study on the evaluation of consciousness disorders in patients with acute drug poisoning using an automatic pupil measurement device
Acronym
Relationship between acute drug poisoning and pupil response
Scientific Title
Evaluation of the usefulness of an automatic pupil measurement device for diagnosing consciousness disorders in patients with acute drug poisoning: A single-center prospective observational study
Scientific Title:Acronym
Automated Detection of Awareness in Poisoned Toxicology patients: ADAPT STUDY
Region
| Japan |
Condition
Condition
Acute Drug Intoxication
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to use an automatic pupil measurement device in patients with acute drug poisoning to clarify the relationship between pupil response and the severity of consciousness impairment. Furthermore, we will examine the extent to which pupil response indicators (such as NPi) correlate with the severity of consciousness impairment, clinical outcomes, and organ dysfunction, and comprehensively evaluate the clinical utility of this device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupil response index measured by an automatic pupil measurement device
Key secondary outcomes
Consciousness impairment (Glasgow Coma Scale, JCS: Japan Coma Scale)
Correlation coefficient between pupil response indicators and Glasgow Coma Scale, Japan Coma Scale
Pupil diameter
Speed of light reflex
Oxygen administration
Presence of tongue base depression
Outcome (hospitalization, discharge, transfer, return home)
Length of stay in the intensive care unit
SOFA score
Types of medications administered, etc.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases diagnosed with acute drug poisoning or strongly suspected of acute drug poisoning who visited the emergency department.
Key exclusion criteria
Individuals under the age of 18
Individuals who did not consent to participate in the study
Cases where pupil response measurement was difficult for any reason (e.g., history of surgery, trauma, etc.)
Cases with obvious central nervous system disorders (e.g., cerebral hemorrhage, cerebral infarction, epilepsy, etc.)
Cases where pupil measurement using an automatic pupil measurement device was not performed prior to discharge or return home
Cases where consent to participate in the study was withdrawn
In cases of unexpected adverse events
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | RYUTO |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Yamagata University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
9909585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
0236331122
ryusi0311@gmail.com
Public contact
Name of contact person
| 1st name | RYUTO |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Yamagata University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
9909585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285422
Homepage URL
ryusi0311@gmail.com
Sponsor or person
Institute
Yamagata Univercity
Institute
Department
Personal name
Funding Source
Organization
Yamagata Univercity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Faculty of Medicine, Yamagata University
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
Tel
0236331122
yu-ikekenkyu@jm.kj.yamagata-u.ac.jp
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
| 2025 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
Case-Control Study
Patients who visited our facility between the date of approval and March 31 2028 and met the inclusion criteria
Primary Outcome
Measure Pupillary response index measured by an automatic pupillary measurement device
Secondary Outcome
Measures Impaired consciousness GCS JCS
Correlation coefficient between pupillary response index and GCS JCS
Pupillary diameter
Speed of light reflex
Presence or absence of oxygen administration
Presence or absence of tongue base depression
Outcome hospitalization discharge transfer return home
Length of stay in the intensive care unit
SOFA score
Types of medications administered etc
Inclusion criteria
Aged 18 years or older and under 100 years
Patients who visited the emergency department with a diagnosis or strong suspicion of acute drug poisoning
Exclusion criteria
Patients under 18 years of age
Individuals who did not consent to the study
Cases where pupil response measurement was difficult for any reason eg surgical history trauma history
Cases with obvious central nervous system disorders eg cerebral hemorrhage cerebral infarction epilepsy
Cases where pupil measurement using an automatic pupil measurement device was not performed prior to hospitalization or discharge
Management information
Registered date
| 2025 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066201
