UMIN-CTR Clinical Trial

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

Patients undergo elective surgery under general anesthesia

Classification by specialty

Pneumology	Anesthesiology	Operative medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Correlation between the end-expiratory CO2 gas pressure and pulmonary artery blood flow.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

tisd@shinshu-u.ac.jp

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

Email

tisd@shinshu-u.ac.jp

Institute

Shinshu University of Medicine

Institute

Department

Personal name

Organization

Shinshu University of Medicine Department of Anesthesiology and Resuscitology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical committee of Shinshu University of Medicine

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

Tel

0263-37-2572

Email

mdrinri@shinshu-u.ac.jp

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

Date of disclosure of the study information

2018

Year

05

Month

10

Day

URL releasing protocol

https://link.springer.com/article/10.1007/s00424-021-02586-3

Publication of results

Unpublished

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

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 related information

nothing

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