UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059529 |
|---|---|
| Receipt number | R000068093 |
| Scientific Title | Efficacy of Ultrasound-Guided Distal Radial Artery Catheterization versus Radial Artery Catheterization in Prone Position Surgery and the Effects on Intraoperative Arterial Pressure Waveforms: a randomised controlled trial. |
| Date of disclosure of the study information | 2025/10/24 |
| Last modified on | 2025/10/24 13:11:20 |
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Basic information
Public title
Efficacy of Ultrasound-Guided Distal Radial Artery Catheterization versus Radial Artery Catheterization in Prone Position Surgery and the Effects on Intraoperative Arterial Pressure Waveforms: a randomised controlled trial.
Acronym
Efficacy of Ultrasound-Guided Distal Radial Artery Catheterization versus Radial Artery Catheterization in Prone Position Surgery and the Effects on Intraoperative Arterial Pressure Waveforms: a randomised controlled trial.
Scientific Title
Efficacy of Ultrasound-Guided Distal Radial Artery Catheterization versus Radial Artery Catheterization in Prone Position Surgery and the Effects on Intraoperative Arterial Pressure Waveforms: a randomised controlled trial.
Scientific Title:Acronym
Efficacy of Ultrasound-Guided Distal Radial Artery Catheterization versus Radial Artery Catheterization in Prone Position Surgery and the Effects on Intraoperative Arterial Pressure Waveforms: a randomised controlled trial.
Region
| Japan |
Condition
Condition
Prone Position Surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares the radial artery and distal radial artery for ultrasound-guided arterial pressure line insertion using a T-shaped probe in patients undergoing prone position surgery, evaluating the rate of arterial pressure waveform damping during surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of intraoperative arterial pressure waveform damping
Key secondary outcomes
First-attempt success rate
Number of attempts until successful puncture
Time required for successful puncture
Time to catheter fixation
Incidence of posterior wall puncture
Ultrasound assessment:
Diameter of the target artery
Depth from skin to the artery
Cross-sectional area
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Insertion of arterial line from distal radial artery
Interventions/Control_2
Insertion of arterial line from radial artery
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 15 years or older undergoing scheduled surgery in the prone position who require invasive arterial pressure monitoring
Key exclusion criteria
Patients with signs of infection at the puncture site.
Patients with coagulopathy.
Patients with a history of peripheral arterial disease.
Patients undergoing surgery in which intraoperative observation of the insertion site is anticipated to be difficult.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Taiji |
| Middle name | |
| Last name | Okamoto |
Organization
Keio University School of Medicine
Division name
department of anesthesiology
Zip code
1600016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
taijiokamoto0904@gmail.com
Public contact
Name of contact person
| 1st name | Taiji |
| Middle name | |
| Last name | Okamoto |
Organization
Keio University School of Medicine
Division name
department of anesthesiology
Zip code
1600016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
taijiokamoto0904@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
0333531211
taijiokamoto0904@gmail.com
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
| 2025 | Year | 10 | Month | 24 | 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
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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 | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068093
