UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055218 |
|---|---|
| Receipt number | R000062735 |
| Scientific Title | A study of ultrasound probe processing methods in the emergency department: a single-centre, single-blind, randomized, controlled trial |
| Date of disclosure of the study information | 2024/08/12 |
| Last modified on | 2024/10/31 14:00:47 |
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Basic information
Public title
A study of ultrasound probe processing methods in the emergency department: a single-centre, single-blind, randomized, controlled trial
Acronym
Trophon study
Scientific Title
A study of ultrasound probe processing methods in the emergency department: a single-centre, single-blind, randomized, controlled trial
Scientific Title:Acronym
Trophon study
Region
| Japan |
Condition
Condition
Any emergency diseases
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether treatment of probes that have been used on or contaminated by patients with a reprocessing flow using the Nanosonics trophon2 ultrasound probe cleaner/disinfector (hereinafter trophon2) can reduce contamination immediately before patient use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Ultrasonic probe contamination rate (bacterial detection rate, bacterial colony count)
Key secondary outcomes
bacterial species
Sample collection time
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
<trophon2 group>
Remove the ultrasonic probe from the ultrasonic device, reprocess it using trophon2, attach the probe cover after reprocessing, and connect it to the ultrasonic device. If the probe cover comes off unintentionally, reprocess the probe using trophon2 again and reattach the probe cover after reprocessing.
Interventions/Control_2
<Standard wiping group>
The subject ultrasound probe should be wiped with a dry wipe or a wet towel moistened with water while still connected to the ultrasound machine. Additional wiping with ethanol wipes may be added at the discretion of the physician who used the machine.
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
ultrasound probe used on a patient in the emergency room or equally contaminated
Key exclusion criteria
Probe deemed inappropriate for inclusion in the study by the physician who used it
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Sasaki |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
0332251323
sasaki.junichi@z8.keio.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
0332251323
Homepage URL
ryoyamamoto@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Nanosonics Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Institutional Review Board
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
0333531211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2024 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062735
