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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010322
Receipt No. R000012081
Scientific Title The correlation between postoperative atrial fibrillation and right ventricular function in lung surgery.
Date of disclosure of the study information 2013/03/27
Last modified on 2017/04/28

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Basic information
Public title The correlation between postoperative atrial fibrillation and right ventricular function in lung surgery.
Acronym The correlation between postoperative atrial fibrillation and right ventricular function in lung surgery.
Scientific Title The correlation between postoperative atrial fibrillation and right ventricular function in lung surgery.
Scientific Title:Acronym The correlation between postoperative atrial fibrillation and right ventricular function in lung surgery.
Region
Japan

Condition
Condition postoperative atrial fibrillation
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this prospective observational study is to identify the correlation between postoperative atrial fibrillation and right ventricular function in pneumonectomy by using intraoperative transesophageal echocardiography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of postoperative atrial fibrillation.
intraoperative transechocardiographic findings such as early diastolic tricuspid inflow velocity, early diastolic tricuspid annulus velocity, right ventricular fractional area change and tricuspid annular plane systolic excursion.
Key secondary outcomes

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
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patinets undergoing elective pneumonectomy
Key exclusion criteria Patients with abnormal electrocardiographic findings such as atrial fibrillation,heart disease.
Hemodialysis patinets.
Patients undergoing redo lung surgery.
Patients with comorbidities contraindicating transesophageal echocardiography.
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norikatsu Mita
Organization Saitama cardiovascular and respiratory center
Division name Anesthesiology
Zip code
Address 1696 Itai, Kumagaya, Saitama, Japan
TEL 048-536-9900
Email mita.norikatsu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Norikatsu Mita
Organization Saitama cardiovascular and respiratory center
Division name Anesthesiology
Zip code
Address 1696 Itai, Kumagaya, Saitama, Japan
TEL 048-536-9900
Homepage URL
Email mita.norikatsu@gmail.com

Sponsor
Institute Saitama cardiovascular and respiratory center
Institute
Department

Funding Source
Organization Saitama cardiovascular and respiratory center
Organization
Division
Category of Funding Organization Local Government
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
2013 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Open public recruiting
Date of protocol fixation
2013 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All enrolled patients are monitored with ECG after operation to detect postoperative atrial fibrillation.
Intraoperative transesophageal echocardiography is performed at 2 time points:1. before lobectomy and 2. after lobectomy in operating room.
We assess parameters as follows:
early diastolic tricuspid inflow velocity,
early diastolic tricuspid annulus velocity, Systolic velocity, right ventricular fractional area change and tricuspid annular plane systolic excursion.

Management information
Registered date
2013 Year 03 Month 26 Day
Last modified on
2017 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012081

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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