UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050973 |
|---|---|
| Receipt number | R000058099 |
| Scientific Title | Research on infusion method and administration rate in confined space required for rescue-medical collaboration in disaster on-site activities |
| Date of disclosure of the study information | 2023/05/02 |
| Last modified on | 2023/10/09 17:11:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on infusion method and administration rate in confined space required for rescue-medical collaboration in disaster on-site activities
Acronym
Research on infusion in disaster activities
Scientific Title
Research on infusion method and administration rate in confined space required for rescue-medical collaboration in disaster on-site activities
Scientific Title:Acronym
Research on infusion in disaster activities
Region
| Japan |
Condition
Condition
Healthy male volunteers aged 20-29
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Create an intravenous infusion model based on the results of infusion studies on healthy human volunteers and conduct an exploratory study of the administration rate of various infusion methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, height, weight, and medical history of study subjects; amount of water consumed in the 12 hours prior to the start of the study; differences in last drinking time; central venous diameter and respiratory variability; venous diameter and blood flow velocity at the peripheral venipuncture site in the forearm; and differences in infusion administration rate due to peripheral venous pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The peripheral vein is secured with a 20G intravenous needle in the forearm, and 500ml of lactate Ringer's solution is given as a full-open infusion.
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
| 20 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
Student of Aichi Medical University Faculty of Medicine
Key exclusion criteria
Having some medical history (especially cardiovascular disease, upper extremity vascular or lymphatic problems, or dialysis shunts). Extremely skinny or obese (BMI less than 18 or more than 30). Other persons deemed inappropriate by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Irahara |
Organization
Aichi Medical University Hospital
Division name
Department of Emergency and Critical Care Medicine / Advanced Critical Care Center
Zip code
4801195
Address
1-1, Yazakokarimata, Nagakute-city, Aichi
TEL
0561623311
t-irahara@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Irahara |
Organization
Aichi Medical University Hospital
Division name
Department of Emergency and Critical Care Medicine / Advanced Critical Care Center
Zip code
4801195
Address
1-1, Yazakokarimata, Nagakute-city, Aichi
TEL
0561623311
Homepage URL
t-irahara@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
General Foundation for the Promotion of First Aid
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
Aichi Medical University Hospital
Address
1-1, Yazakokarimata, Nagakute-city, Aichi
Tel
0561623311
t-irahara@aichi-med-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 | 05 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://fasd.jp/files/libs/5434/202309210955429566.pdf
Number of participants that the trial has enrolled
20
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
| 2023 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058099
