UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051412 |
|---|---|
| Receipt number | R000058641 |
| Scientific Title | An observational study of diagnostic accuracy of ELSTs on anaphylaxis |
| Date of disclosure of the study information | 2023/06/22 |
| Last modified on | 2023/06/22 10:49:10 |
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Basic information
Public title
An observational study of diagnostic accuracy of ELSTs on anaphylaxis
Acronym
An observational study of diagnostic accuracy of ELSTs on anaphylaxis
Scientific Title
An observational study of diagnostic accuracy of ELSTs on anaphylaxis
Scientific Title:Acronym
An observational study of diagnostic accuracy of ELSTs on anaphylaxis
Region
| Japan |
Condition
Condition
anaphylactic shock
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of detecting anaphylaxis by ELSTs
Basic objectives2
Others
Basic objectives -Others
Diagnostic accuracy
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive predictive value
Key secondary outcomes
Positive likelihood ratio
Negative predictive value
Sensitivity
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Emergency life-saving technicians who responded to an emergency call from a patient suspected of anaphylaxis
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Sakamoto |
Organization
School of Medicine, Teikyo University
Division name
Department of Emergency Medicine
Zip code
173-8606
Address
2-11-1, Kaga, Itabashiku, Tokyo
TEL
03-3964-3023
sakamoto.tetsuya@nifty.ne.jp
Public contact
Name of contact person
| 1st name | yasufumi |
| Middle name | |
| Last name | katagiri |
Organization
School of Medicine, Teikyo University
Division name
Department of Emergency Medicine
Zip code
173-8606
Address
2-11-1, Kaga, Itabashiku, Tokyo
TEL
03-3964-3023
Homepage URL
https://kyumeisi-training.jp/
katagr@med.teikyo-u.ac.jp
Sponsor or person
Institute
Health , Labour and Welfare Sciences Research GrantsResearch on Region Medical
Institute
Department
Personal name
Funding Source
Organization
Health , Labour and Welfare Sciences Research GrantsResearch on Region Medical
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Medical Research Ethics Committee
Address
2-11-1, Kaga, Itabashiku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-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
| 2023 | Year | 06 | Month | 22 | 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
| 2023 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design: a prospective observational study. Aim and Methods: to evaluate the ability of emergency life-saving technicians (ELSTs) to diagnose anaphylaxis by comparing the diagnoses of anaphylaxis requiring adrenaline administration by ELSTs in the field with those made by physicians at medical institutions after transport. The study will evaluate the positive predictive value and positive likelihood ratio and others of the decisions by ELSTs against the decisions by the physicians. The selection of ELSTs will be done through public recruitment to organizations such as prefectural and regional medical control (MC) committees and fire departments. ELSTs who belong to participating organizations will be provided with explanatory documents and videos and asked to provide consent. The study team will guide ELSTs who have completed the preparatory e-learning (which includes the overview of the study, basic knowledge of anaphylaxis, judgments of anaphylaxis and adrenaline administration in this study, and the use of observation cards) to collect data.
Management information
Registered date
| 2023 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058641
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
