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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000040000 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | disturbance of consciousness | ||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Organization | Tokyo Medical University Hospital
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Division name | Emergency and Critical Care Center | ||||||
Zip code | 1600023 | ||||||
Address | Nishisinjuku6,Shinjuku-ku,Tokyo 160-0023 Japan | ||||||
TEL | 0333426111 | ||||||
ymngufdream@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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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 |
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Last modified on |
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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 |