UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050117 |
|---|---|
| Receipt number | R000057094 |
| Scientific Title | Comparison of ultrasound-guided radial artery catheterization by using T-type probe with that by conventional linear probe: a randomized controlled trial |
| Date of disclosure of the study information | 2023/01/25 |
| Last modified on | 2023/10/13 06:50:01 |
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Basic information
Public title
Comparison of ultrasound-guided radial artery catheterization by using T-type probe with that by conventional linear probe
Acronym
Comparison of ultrasound-guided radial artery catheterization by using T-type probe with that by conventional linear probe
Scientific Title
Comparison of ultrasound-guided radial artery catheterization by using T-type probe with that by conventional linear probe: a randomized controlled trial
Scientific Title:Acronym
Comparison of ultrasound-guided radial artery catheterization by using T-type probe with that by conventional linear probe: a randomized controlled trial
Region
| Japan |
Condition
Condition
the operation scheduled patients who are necessary to radial artery catheterization
Classification by specialty
| Anesthesiology | Operative medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to comparison the ultrasound-guided radial artery catheterization by using T-type probe with that by using conventional linear probe
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the fist attempt success rate of radial artery catheterization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
the study period: 2 days
the objects: the operation scheduled patients who more than 20 years old , and are necessary to radial artery catheterization
methods : After the induction of general anesthesia, the anesthesiologists perform the long-axis in-plane ultrasound-guided radial artery catheterization by using the conventional linear probe. If the systolic blood pressure is less than 80 mmHg, the anesthesiologists modify the concentration of anesthetic agents or administer vasopressor drugs.
Interventions/Control_2
the study period: 2 days
the objects: the operation scheduled patients who more than 20 years old , and are necessary to radial artery catheterization
methods : After the induction of general anesthesia, the anesthesiologists perform ultrasound-guided radial artery catheterization by using the T-type probe. If the systolic blood pressure is less than 80 mmHg, the anesthesiologists modify the concentration of anesthetic agents or administer vasopressor drugs.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the operation scheduled patients who are necessary to radial artery catheterization
Key exclusion criteria
1. the patients who were not got the agreement of the study
2. PT-INR is more than 2
3. APTT is more than 54 sec
4. platelet count is less than 50000
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
291, S1, W16, Chuo-ku, Sapporo
TEL
011-611-2111
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Igarashi |
Organization
The secretariat of Sapporo Medical University School of Medicine
Division name
The clinical study section
Zip code
0608543
Address
291, S1, W16, Chuo-ku, Sapporo
TEL
0116112111
Homepage URL
ji-rskk@sapmed.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The secretariat of Sapporo Medical University School of Medicine
Address
291, S1, W16, Chuo-ku, Sapporo
Tel
0116112111
ji-rskk@sapmed.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 | 01 | Month | 25 | 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
150
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 10 | 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 | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057094
| 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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