UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016434 |
|---|---|
| Receipt number | R000019083 |
| Scientific Title | A utility of ultrasound-guided PICC catheterization |
| Date of disclosure of the study information | 2015/02/03 |
| Last modified on | 2024/03/29 16:50:05 |
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Basic information
Public title
A utility of ultrasound-guided PICC catheterization
Acronym
USGPICC
Scientific Title
A utility of ultrasound-guided PICC catheterization
Scientific Title:Acronym
USGPICC
Region
| Japan |
Condition
Condition
Surgery,Oto-rhino-laryngology,Dental medecine
Classification by specialty
| Surgery in general | Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
All this time, we use chest X-ray to catheterize PICC.If we suggest the utility of this ultrasound-guided method, catheterization at bedside will make staffs unbusy. We expected the PICC length to insert by body landmark and ultrasound methods, and compare the difference.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distance between catheter tips and the carina with the landmark or ultrasound method. Comfirmation not to placing catheters in internal jugular vein.
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
| Maneuver |
Interventions/Control_1
Compare the length of three method. A method of body landmark, of ultrasound method, and of catherization tips on the carina.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients scheduling PICC catheterization
Key exclusion criteria
The patients contraindicated for inserting PICC, BMI over 35, the patients who has abnormality of arm angioplany
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | TATUO |
| Middle name | |
| Last name | NAKAMOTO |
Organization
Osaka Rosai Hospital
Division name
Department of anethesiology
Zip code
5918025
Address
3-1179NagasonechoKitakuSakaicity
TEL
0722523561
tnakamoto@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | RINA |
| Middle name | |
| Last name | HORIE |
Organization
Osaka Rosai Hospital
Division name
Department of anethesiology
Zip code
5918025
Address
3-1179NagasonechoKitakuSakaicity
TEL
0722523561
Homepage URL
rhorie@koto.kpu-m.ac.jp
Sponsor or person
Institute
Osaka Rosai Hospital Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
none
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
Osaka Rosai Hospital
Address
3-1179NagasonechoKitakuSakaicity
Tel
0722523561
soumukatyou@org.go.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
| 2015 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
27
Results
Twenty-seven patients were observed over a 6-month period. Of these, one patient had a very thin vein and gave up on the implantation itself. 23 of 26 patients were successfully implanted under ultrasound guidance, with a fixation length (U) of 33.9 (average) cm and a fixation length (X) of 35.1 (average) cm, in good agreement with a bias of -1.2 (average) cm and a 95% agreement limit of -6.1 to 3.8 cm (Figure).
Results date posted
| 2024 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adult patients with perioperative PICC placement
Participant flow
Requests anesthesiology for PICC implantation
Adverse events
non
Outcome measures
In the operating room, the ulnar vein of the right upper arm was punctured under ultrasound guidance, and the PICC tip was drawn at the confluence of the internal jugular and subclavian veins. Next, under fluoroscopic guidance, the PICC tip was adjusted 1 cm caudal to the tracheal bifurcation to determine the fixation length (X). The objectives were 1) to demonstrate non-inferiority of fixation length (U) and 2) to ensure that the PICC was placed in the central vein without straying into the internal jugular vein.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019083
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