UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027418 |
|---|---|
| Receipt number | R000031419 |
| Scientific Title | Anatomic and phoysiological ablnomarity influences pulmonary artery catheter placement in anesthetized patients. |
| Date of disclosure of the study information | 2017/05/21 |
| Last modified on | 2020/06/03 14:34:16 |
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Basic information
Public title
Anatomic and phoysiological ablnomarity influences pulmonary artery catheter placement in anesthetized patients.
Acronym
Anatomic and physiological abnormality and pulmonary artery catheter.
Scientific Title
Anatomic and phoysiological ablnomarity influences pulmonary artery catheter placement in anesthetized patients.
Scientific Title:Acronym
Anatomic and physiological abnormality and pulmonary artery catheter.
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery
Classification by specialty
| Anesthesiology | Operative medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether anatomical abnormality (enlargement of the aortic root and proximal ascending aorta, etc)and physiological abnormality (tricuspid valve regaergitation, cardiac dysfunction, etc) may prolong placement of a pulmonary atery catheter .
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The catheter placement time which is defined as the duration of time required for the catheter to float from the CVP position to the pulmonary artery.
Key secondary outcomes
Venttricular arrhythmias during catheter placement
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing elective cardiovascular surgery who requires placement of a pulmonary artery catheter
Key exclusion criteria
The patients who had a history of tricuspid ring annuloplasty
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Hayashi |
Organization
Sakurabashi-Watanabe Hospital
Division name
Anesthesiology Service
Zip code
530-0001
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 | Yukio |
| Middle name | |
| Last name | Hayashi |
Organization
Sakurabashi- Watanabe Hospital
Division name
Anesthesiology
Zip code
530-0001
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sakurabashi-Watanabe Hospital IRB
Address
2-432, Umeda, Kita-ku, Osaka, Japan
Tel
06-6341-8651
i_oka@watanabe-hsp.or.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
桜橋渡辺病院（大阪市）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1. The present data showed that the diameter of aortic root is a significant factor to increase the PAC placement time.
2. Experience of physician who place the pulmonary artery catheter is an important factor. Our data suggested that 20 cases may be required to standard level for the catheter placement from zero experience.
3. The catheter placement through the left internal jugulara vein needs more time to pass through the tricuspid valve.
Results date posted
| 2019 | Year | 10 | Month | 21 | Day |
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
1.Results 1:Presentation at the ASA meeting of 2016
Pubrished:JA Clinical Reports 2018; 4:15
2. Results 2:Presentation at Annual Meeting Japan Soceity of Anesthesiologists of 2018 and Annual Meeting Japan Soceity of Anesthesiologists Kanasai Branch of 2019
Published: Accepted at Annual Cardiac Anesth
3.Results 3:Presentation at Annual Meeting Japan Soceity of Anesthesiologists of 2020
Management information
Registered date
| 2017 | Year | 05 | Month | 20 | Day |
Last modified on
| 2020 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031419
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