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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000030025
Receipt No. 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

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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
Email 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
Email yhayashi@anes.med.osaka-u.ac.jp

Sponsor
Institute Sakurabashi-Watanabe Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034287

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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