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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036070
Receipt No. R000041090
Scientific Title Investigation on exhalation gas in patients undergoing cardiac surgery or thoracic aortic surgery using cardiopulmonary bypass
Date of disclosure of the study information 2019/03/04
Last modified on 2019/03/03

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Basic information
Public title Investigation on exhalation gas in patients undergoing cardiac surgery or thoracic aortic surgery using cardiopulmonary bypass
Acronym Investigation on exhalation gas in patients undergoing cardiac surgery or thoracic aortic surgery using cardiopulmonary bypass
Scientific Title Investigation on exhalation gas in patients undergoing cardiac surgery or thoracic aortic surgery using cardiopulmonary bypass
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazumi Funaki
Organization Tottori University
Division name Division of Anesthesiology and Critical Care Medicine
Zip code
Address 36-1, Nishi-cho, Yonago, Tottori, Japan
TEL 0859-38-6657
Email funapon1116@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Funaki
Organization Tottori University
Division name Division of Anesthesiology and Critical Care Medicine
Zip code
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)

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 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

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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
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

Other
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

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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