UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036070 |
|---|---|
| Receipt number | 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 22:58:52 |
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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
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
funapon1116@gmail.com
Sponsor or person
Institute
Division of Anesthesiology and Critical Care Medicin, Tottori University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041090
