UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037631 |
|---|---|
| Receipt number | R000042908 |
| Scientific Title | A prospective clinical study on new insertion sites and fixation methods for arterial lines |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/08/08 12:13:36 |
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Basic information
Public title
A prospective clinical study on new insertion sites and fixation methods for arterial lines
Acronym
New insertion sites of arterial line
Scientific Title
A prospective clinical study on new insertion sites and fixation methods for arterial lines
Scientific Title:Acronym
New insertion sites of arterial line
Region
| Japan |
Condition
Condition
Patients who need invasive arterial pressure measurement who visited our emergency & disaster medical center
Classification by specialty
| Medicine in general | Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is inserting an arterial pressure line from the distal radial artery will reduce accidental removal and reduce the incidence of Medical Device Related Pressure Ulcer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accidental removal rate of arterial line During in intensive care unit
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
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 traditional 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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patient
Patients who need arterial pressure monitoring because of continuous arterial pressure measurement and frequent blood tests
Key exclusion criteria
Patients with trauma or skin lesions at the puncture site at the distal radial artery
Patients who have dialysis shunts cannot puncture the upper limbs
Patient who cannot fix the puncture needle because of Very thin
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Maruhashi |
Organization
Kitasato University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
252-0375
Address
1-15-1 KITASATO,MINAMI-KU,SAGAMIHARA KANAGAEA, 252-0375,JAPAN
TEL
042-778-8111
tmaruhasi@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Marina |
| Middle name | |
| Last name | Oi |
Organization
Kitasato University Hospital
Division name
Emergency & Disaster Medical Center
Zip code
252-0375
Address
1-15-1 KITASATO,MINAMI-KU,SAGAMIHARA KANAGAEA, 252-0375,JAPAN
TEL
042-778-8111
Homepage URL
marina.oi.1992@gmail.com
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Kitasato University Hospital
Address
1-15-1 KITASATO,MINAMI-KU,SAGAMIHARA KANAGAEA, 252-0375,JAPAN
Tel
042-778-8111
marina.oi.1992@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
| 2019 | Year | 09 | Month | 01 | 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
| 2019 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042908
