UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049165 |
|---|---|
| Receipt number | R000055922 |
| Scientific Title | Validation of automated pupillometry in the intensive care unit for predicting neurological outcome. |
| Date of disclosure of the study information | 2022/10/12 |
| Last modified on | 2024/04/11 05:24:29 |
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Basic information
Public title
Validation of automated pupillometry in the intensive care unit for predicting neurological outcome.
Acronym
Validation of automated pupillometry in the intensive care unit for predicting neurological outcome.
Scientific Title
Validation of automated pupillometry in the intensive care unit for predicting neurological outcome.
Scientific Title:Acronym
Validation of automated pupillometry in the intensive care unit for predicting neurological outcome.
Region
| Japan |
Condition
Condition
Cardiovascular surgery patients
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pupil diameter index of automatic pupillometers in critically ill patients not affected by analgesic and sedative drugs and catecholamine preparations.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between the pupil diameter index and the onset of delirium.
To determine whether the above pupil diameter index can be applied to predict the onset of delirium and to quantitatively assess cognitive dysfunction in the short and long term.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes over time in the pupil diameter index of the automatic pupillometer from preoperative to postoperative
Key secondary outcomes
Relationship between Pupillary Diameter Index of Automatic Pupillometers and Incidence of Delirium
Pupil Diameter Index of Auto-Pupillometers in Relation to Short- and Long-Term Cognitive Dysfunction
Relationship between the pupil diameter index of the automated pupillometer and post-extubation restlessness
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients on the waiting list for cardiovascular surgery
Patients who have been intubated and successfully extubated within 24 hours after surgery.
Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will after full understanding of the study.
Key exclusion criteria
Patients who have a disease that causes impaired consciousness due to central nervous system disorder at the time of admission.
(e.g., stroke, severe head injury, post-operative neurosurgery, cardiopulmonary resuscitation, CNS degenerative disease, etc.)
Patients with postoperative ophthalmologic diseases (cataract, glaucoma, retinopathy due to diabetes, etc.)
Patients who have difficulty in speaking (e.g., dementia, psychiatric disorders, autism, foreigners who have difficulty in speaking Japanese)
Other patients who are deemed inappropriate as subjects by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Saiko |
| Middle name | |
| Last name | Okamoto |
Organization
Hitachi General Hospital
Division name
intensive care unit
Zip code
3170077
Address
317-0077 Ibaraki, Japan.
TEL
0294-23-1111
chara.ponpoco@gmail.com
Public contact
Name of contact person
| 1st name | Saiko |
| Middle name | |
| Last name | Okamoto |
Organization
Hitachi General Hospital
Division name
intensive care unit
Zip code
3170077
Address
317-0077 Ibaraki, Japan.
TEL
0294-23-1111
Homepage URL
chara.ponpoco@gmail.com
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research - Japan Society for the Promotion of Science
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
Hitachi General Hospital
Address
317-0077 Ibaraki, Japan.
Tel
0294-23-1111
masahiro.miura.cz@hitachi.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
| 2022 | Year | 10 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Research Design)
Prospective observational study
(Study Subject)
Patients who underwent standby surgery in our cardiovascular surgery department from October 12, 2022 to March 31, 2024 and met the selection criteria. Patients who had undergone standby surgery in cardiovascular surgery at our hospital between October 12, 2022 and March 31, 2024 and met the selection criteria
Management information
Registered date
| 2022 | Year | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055922
