UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation on exhalation gas in patients undergoing cardiac surgery or thoracic aortic surgery using cardiopulmonary bypass
Title of the study (Brief title)	Investigation on exhalation gas in patients undergoing cardiac surgery or thoracic aortic surgery using cardiopulmonary bypass
Region	Japan

Condition
Condition	cardiac surgery, thoracic aortic surgery
Classification by specialty	Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In patients undergoing cardiac surgery or thoracic aortic surgery using cardiopulmonary bypass, we measure the expiratory concentration of various biological gases at the perioperative period and evaluate the effectiveness of surgery. And we measure the exhaust gas concentration of cardiopulmonary bypass if possible and evaluate the effectiveness of surgery. In addition, we investigate the relevance of the change in breath concentration of various biological gases with cytokine, ROS, biomarker, surgical contents and respiratory function.
Basic objectives2	Others
Basic objectives -Others	Epidemiological study
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	change in breath concentration of various biological gases during perioperative period(and change in exhaust gas concentration of cardiopulmonary bypass if possible)
Key secondary outcomes	1) relevance of breath concentration of various biological gases and blood cytokines during perioperative period 2) relevance of breath concentration of various biological gases and blood ROS during perioperative period 3) relevance of breath concentration of various biological gases and biomarkers during perioperative period 4) relevance of breath concentration of various biological gases and various inspections during perioperative period 5) relevance of breath concentration of various biological gases and respiratory function during perioperative period 6) relevance of breath concentration of various biological gases and the cardiopulmonary bypass time during perioperative period 7) relevance of breath concentration of various biological gases and surgical contents during perioperative period 8) relevance of exhaust gas concentration of cardiopulmonary bypass and manufactured products of cardiopulmonary bypass during perioperative period

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)patients over 20 years at the time of obtaining informed consent 2)patients scheduled to undergo total intravenous anesthesia 3)patients scheduled for cardiac surgery or thoracic aortic surgery using cardiopulmonary bypass
Key exclusion criteria	1)patients scheduled to undergo maintenance by volatile anesthesia 2)patients undergoing surgery requiring general anesthesia within 3 months prior to obtaining informed consent 3)patients with respiratory dysfunction 4)patients with severe lung disease 5)patients with smoking history within 3 months before consent acquisition 6)diabetic patients with poor control 7)patients with severe liver disease 8)patients with severe kidney disease 9)patients who receive chemotherapy, radiation therapy, immunotherapy within 3 months prior to obtaining informed consent 10)patients with systemically or locally active infections 11)highly obese patients 12)women who may be pregnant or have a possibility of pregnancy 13)patients who received study drugs or investigational drugs within 3 months prior to obtaining informed consent 14)patinets whom research investigator has determined to be inappropriate
Target sample size	20

Research contact person
Name of lead principal investigator	Kazumi Funaki
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Email	funapon1116@gmail.com

Public contact
Name of contact person	Kazumi Funaki
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Homepage URL
Email	funapon1116@gmail.com

Sponsor
Institute	Division of Anesthesiology and Critical Care Medicin, Tottori University
Institute
Department

Funding Source
Organization	Division of Anesthesiology and Critical Care Medicin, Tottori University
Organization
Division
Category of Funding Organization	Self funding
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	鳥取大学医学部附属病院（鳥取県）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 04 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 03 Month 04 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	In patients undergoing cardiac surgery or thoracic aortic surgery using cardiopulmonary bypass, we measure the expiratory concentration of various biological gases at the perioperative period and evaluate the effectiveness of surgery. And we measure the exhaust gas concentration of cardiopulmonary bypass if possible and evaluate the effectiveness of surgery. In addition, we investigate the relevance of the change in breath concentration of various biological gases with cytokine, ROS, biomarker, surgical contents and respiratory function.

Management information
Registered date	2019 Year 03 Month 03 Day
Last modified on	2019 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041090