UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057995 |
|---|---|
| Receipt number | R000066298 |
| Scientific Title | A Randomized Controlled Trial Investigating the Impact of Patient Clothing on Bystander Use of Automated External Defibrillators (AEDs) |
| Date of disclosure of the study information | 2025/05/28 |
| Last modified on | 2026/02/06 10:05:22 |
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Basic information
Public title
A Study on the Influence of Patient Clothing on Bystander Application of Automated External Defibrillators
Acronym
CLOTH-AED Study
Scientific Title
A Randomized Controlled Trial Investigating the Impact of Patient Clothing on Bystander Use of Automated External Defibrillators (AEDs)
Scientific Title:Acronym
CLOTH-AED Trial
Region
| Japan |
Condition
Condition
Out-of-Hospital Cardiac Arrest (OHCA)
Classification by specialty
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Early use of an automated external defibrillator (AED) is critical for the survival of patients with out-of-hospital cardiac arrest (OHCA). Applying an AED requires the removal of clothing from the chest area, yet training programs typically use mannequins without clothing. In real-life situations, however, patients are clothed, which can hinder AED use. Previous studies have suggested that clothing may negatively impact the quality of chest compressions. The aim of this study is to evaluate how clothing affects AED application by training participants and to identify an appropriate method of clothing removal that can be performed by lay rescuers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time interval from the arrival of the AED at the patient's side to the delivery of the first defibrillation shock.
Key secondary outcomes
Correctness of AED pad positioning as judged by predefined anatomical landmarks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Scissors Use
Interventions/Control_2
No Scissors Use
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Current students enrolled at Niigata University of Health and Welfare.
Key exclusion criteria
Students enrolled in the Department of Emergency Medical Sciences.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Omatsu |
Organization
Niigata University of Health and Welfare
Division name
Department of Emergency Medical Scienses
Zip code
9503198
Address
1398, Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
0252574641
omatsu@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Omatsu |
Organization
Niigata University of Health and Welfare
Division name
Department of Emergency Medical Scienses
Zip code
9503198
Address
1398, Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
0252574641
Homepage URL
omatsu@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) of Niigata University of Health and Welfare
Address
1398, Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
Tel
025-257-4455
rinri@nuhw.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
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 28 | 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
Completed
Date of protocol fixation
| 2025 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066298
