UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The correlation between postoperative atrial fibrillation and right ventricular function in lung surgery.
Title of the study (Brief title)	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	Norikatsu Mita
Organization	Saitama cardiovascular and respiratory center
Division name	Anesthesiology
Address	1696 Itai, Kumagaya, Saitama, Japan
TEL	048-536-9900
Email	mita.norikatsu@gmail.com

Public contact
Name of contact person	Norikatsu Mita
Organization	Saitama cardiovascular and respiratory center
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 03 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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