Unique ID issued by UMIN | UMIN000017051 |
---|---|
Receipt number | R000019732 |
Scientific Title | Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial |
Date of disclosure of the study information | 2015/04/06 |
Last modified on | 2016/03/28 20:04:03 |
Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial
Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial
Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial
Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial
Japan |
Patients who undergo surgery under general anesthesia at Niigata University Medical and Dental Hospital. In adition, they plan to need radial arterial catheterization and we will be able to access to the catheter insertion site during operation.
Anesthesiology |
Malignancy
NO
An arterial catheter often becomes bent, leading to overamping of pressure waveform and occlusion of a catheter. If the catheter is fixed using a film dressings as described in package insert (conventional method) , the catheter is likely to be bent at the insertion site due to its compresssion.
We previously reported that we developed the new fixation method (pillow method) and showed that it keeps a catheter patent better than conventional method (J clin Anesth 2012 ; 36 : 1457-62). Based on this study, we developed the device which we named 'A-namaran'.
The purpose of this study is to see whether the fixation using 'A-namaran' keeps a catheter patent better than the conventional method.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
The need for an intervention to improve catheter bent.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
Fix the arterial catheter using A-namaran.
Fix the arterial catheter by conventional method.
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients who undergo surgery under general anesthesia at Niigata University Medical and Dental Hospital. In adition, they plan to need radial arterial catheterization and we will be able to access to the catheter insertion site during operation.
ASA PS <= 4
>20 years old or <=80 years old
Peripheral vascular disease such as vasculitis
Cannot obtain participant's or his relative's consent
An artery other than radial artery is catherterized
Any other case that the principal investigator or a member of the study judged to be excluded
100
1st name | |
Middle name | |
Last name | Tatsuro Kohno |
Niigata University Medical and Dental Hospital
Department of Anesthesiology
754 Asahimachidoori_ichibanchou, Chuuouku, Niigatashi, Niigata, 951-8520, Japan
0025-223-6161
Kohno-t@umin.net
1st name | |
Middle name | |
Last name | Takeshi Hashimoto |
Niigata University Medical and Dental Hospital
Department of Anesthesiology
754 Asahimachidoori_ichibanchou, Chuuouku, Niigatashi, Niigata, 951-8520, Japan
0025-223-6161
Thashimoto-nii@umin.ac.jp
Niigata University Medical and Dental Hospital
None
Self funding
SUNARROW LIMITED
NO
新潟大学医歯学総合病院
2015 | Year | 04 | Month | 06 | Day |
Unpublished
The incidence of corrective interventions in Group A was significantly lower than that in Group C (4.1% vs. 18.8%, P < 0.05).
Completed
2015 | Year | 04 | Month | 06 | Day |
2015 | Year | 05 | Month | 18 | Day |
2015 | Year | 12 | Month | 14 | Day |
2015 | Year | 12 | Month | 14 | Day |
2015 | Year | 12 | Month | 14 | Day |
2015 | Year | 12 | Month | 14 | Day |
2015 | Year | 04 | Month | 06 | Day |
2016 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019732
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |