UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030025 |
|---|---|
| Receipt number | R000034287 |
| Scientific Title | Does presence of obstruction in the passage of the pulmonary artery catheter hinder the catheter placement? |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2018/05/28 16:43:33 |
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Basic information
Public title
Does presence of obstruction in the passage of the pulmonary artery catheter hinder the catheter placement?
Acronym
obstraction during pulmonary artery palcement
Scientific Title
Does presence of obstruction in the passage of the pulmonary artery catheter hinder the catheter placement?
Scientific Title:Acronym
obstraction during pulmonary artery palcement
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does the presence of obstruction in the passage of the pulmonary artery catheter hinder the catheter placement?
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The pulmonary artery catheter placement time and frequency of ventricular arrhythmias
Key secondary outcomes
None
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients requires placement of pulmonary artery catheter
Key exclusion criteria
Patients failed the catheter placement
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Hayashi |
Organization
Sakurabashi-Watanabe Hospital
Division name
Anesthesiology Service
Zip code
Address
2-4-32, Umeda, Kita-ku, Osaka, JAPAN
TEL
06-6341-8651
yhayashi@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Hayashi |
Organization
Sakurabashi- Watanabe Hospital
Division name
Anesthesiology
Zip code
Address
2-4-32, Umeda, Kita-ku, Osaka, JAPAN
TEL
06-6341-8651
Homepage URL
yhayashi@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Sakurabashi-Watanabe Hospital
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
Address
Tel
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
| 2017 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Placement of a PAC by monitoring the pressure waveform is difficult in a patient with history of tricuspid ring annuloplasty and the placement under X-ray fluoroscopic photographing system is recommended. On the other hand, the placement by monitoring the pressure waveform may be available in a patient with transvenous pacemaker leads and pulmonary stenosis.
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
Main results already published
Date of protocol fixation
| 2014 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 02 | Day |
Other
Other related information
Published
Hamaba H, Miyata Y, Hayashi Y. Pulmonary artery catheter placement in patients with a history of tricuspid ring annuloplasty, with pulmonary stenosis, and with the transvenous pacemaker keads; is it difficult? JA Clinical Reports 2018; 4:26
Management information
Registered date
| 2017 | Year | 11 | Month | 18 | Day |
Last modified on
| 2018 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034287
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
