UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010322 |
|---|---|
| Receipt number | 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 12:44:01 |
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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
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
mita.norikatsu@gmail.com
Sponsor or person
Institute
Saitama cardiovascular and respiratory center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012081
