UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032543 |
|---|---|
| Receipt number | R000036108 |
| Scientific Title | The new physiological concept of carbon dioxide gas exchange in the human lungs. |
| Date of disclosure of the study information | 2018/05/10 |
| Last modified on | 2021/11/11 13:16:52 |
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Basic information
Public title
The new physiological concept of carbon dioxide gas exchange in the human lungs.
Acronym
The new physiological concept of carbon dioxide gas exchange in the human lungs.
Scientific Title
The new physiological concept of carbon dioxide gas exchange in the human lungs.
Scientific Title:Acronym
The new physiological concept of carbon dioxide gas exchange in the human lungs.
Region
| Japan |
Condition
Condition
Patients undergo elective surgery under general anesthesia
Classification by specialty
| Pneumology | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Vascular endothelial cells are constantly exposed to shear stress, the mechanical force generated by blood flow. Recently we demonstrated that shear stress stimulation induced stress strength-dependent H+ release followed by CO2 gas excretion from pulmonary arteriolar endothelial cells in rabbits. However, whether the mechanism exists in human is still unknown
Thus, we investigate the correlation between the end-experatory CO2 gas pressure and pulmonary artery blood flow in human.
Basic objectives2
Others
Basic objectives -Others
physiologic
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the end-expiratory CO2 gas pressure and pulmonary artery blood flow.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergo elective surgery under general anesthesia and are scheduled to be monitored with TEE and Swan-ganz catheter.
Key exclusion criteria
Patients decline participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ishida |
Organization
Shinshu University of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
tisd@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ishida |
Organization
Shinshu University of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
Homepage URL
tisd@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University of Medicine Department of Anesthesiology and Resuscitology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Shinshu University of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
4035
Org. issuing International ID_1
Ethical committee of Shinshu University of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00424-021-02586-3
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00424-021-02586-3
Number of participants that the trial has enrolled
10
Results
An approximately linear relationship between the PetCO2 and Max Vp was observed. The pumping out of 100% BV produced little or no change in the Hct, pH, P mix v CO2, and P mix v O2, respectively. The hemodilution produced by intravenous infusion of PSS caused a significant decrease in the Hct, but not in the PetCO2. In conclusion, another route of CO2 gas excretion, independent of red blood cells, may be involved in human lungs.
Results date posted
| 2021 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients underwent cardiovascular surgery were enrolled in this study.
Participant flow
Patients underwent cardiovascular surgery were enrolled in this study.
Adverse events
none
Outcome measures
We evaluated the end-expiratory CO2 pressure (PetCO2), maximal flow velocity in the pulmonary artery (Max Vp), the inner diameter (ID) of pulmonary artery, pulmonary arterial CO2 pressure (P mix v CO2), pulmonary arterial O2 pressure (P mix v O2), hematocrit (Hct), pH, the concentration of HCO3, and base excess (BE) in mixed venous blood. In addition, the effects of the decrease in Hct infused with physiological saline solution (PSS) on PetCO2 were investigated in the human subjects.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2018 | Year | 05 | Month | 10 | Day |
Last modified on
| 2021 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036108
