UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048249 |
|---|---|
| Receipt number | R000054992 |
| Scientific Title | Evaluation of absolute cerebral tissue oxygen saturation In Patients with Cardiopulmonary Arrest on Arrival |
| Date of disclosure of the study information | 2022/07/03 |
| Last modified on | 2023/03/24 12:42:40 |
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Basic information
Public title
Evaluation of absolute cerebral tissue oxygen saturation In Patients with Cardiopulmonary Arrest on Arrival
Acronym
Absolute cerebral tissue oxygen saturation in Patients with Cardiopulmonary Arrest
Scientific Title
Evaluation of absolute cerebral tissue oxygen saturation In Patients with Cardiopulmonary Arrest on Arrival
Scientific Title:Acronym
Absolute cerebral tissue oxygen saturation in Patients with Cardiopulmonary Arrest
Region
| Japan |
Condition
Condition
Cardiopulmonary arrest
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Predicting resuscitation rates for out-of-hospital cardiac arrest patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of return of spontaneous circulation (ROSC)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Out-of-hospital cardiac arrest (OHCA)
Key exclusion criteria
Patient unable to wear a probe due to skin damage to the forehead area.
Patients who have requested to be excluded through opt-out.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kawaguchi |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
tkawaguchi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kawaguchi |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
Homepage URL
tkawaguchi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyogakubu, Daigakuin Kenkyu Suishinka
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel
044-977-8111
tkawaguchi@marianna-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
| 2022 | Year | 07 | Month | 03 | 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
108
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
| 2022 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study examines the relationship between cerebral tissue oxygen saturation and rate of return of spontaneous circulation in patients with out-of-hospital cardiopulmonary arrest.
Management information
Registered date
| 2022 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054992
