UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054238 |
|---|---|
| Receipt number | R000061917 |
| Scientific Title | Effect of thoracic fluid content on electrical impedance tomography (EIT) measurements |
| Date of disclosure of the study information | 2024/04/23 |
| Last modified on | 2024/12/18 09:45:37 |
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Basic information
Public title
Effect of thoracic fluid content on electrical impedance tomography (EIT) measurements
Acronym
Effect of thoracic fluid content on electrical impedance tomography (EIT) measurements
Scientific Title
Effect of thoracic fluid content on electrical impedance tomography (EIT) measurements
Scientific Title:Acronym
Effect of thoracic fluid content on electrical impedance tomography (EIT) measurements
Region
| Japan |
Condition
Condition
non
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of changes in thoracic fluid content on electrical impedance tomography (EIT) measurements in healthy adults.
Basic objectives2
Others
Basic objectives -Others
It is believed that when negative (positive) pressure is generated in the thoracic cavity by inspiratory (expiratory) efforts, this pressure draws (pushes) blood into (out of) the thoracic cavity, thereby changing the amount of water in the thoracic cavity. It is also known that the amount of water in the thoracic cavity changes with body position, and EIT may be used to detect changes in the amount of water in the thoracic cavity. This study is based on the hypothesis that changes in thoracic water content can be detected by EIT. The purpose of this study is to investigate whether thoracic water content changes with body position (e.g., lower limb elevation) or with the negative (positive) pressure generated in the thoracic cavity by inspiratory (expiratory) effort.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
This study is a prospective, before-and-after comparative study.
The primary objective of this study was to verify whether the impedance values measured by EIT change accordingly when the amount of fluid in the thoracic cavity is increased. Interventions to increase intrathoracic fluid content will include generating negative pressure in the thoracic cavity through a combination of inspiratory effort and flow restriction, and through positional changes (standing, supine, and elevated lower extremities).
After measuring baseline parameters (ventilatory output, airway pressure, flow, resistance, and impedance using EIT) with a ventilometer, techniques to increase intrapleural fluid volume (increasing intrapleural negative pressure with inspiratory effort and flow restriction, or changing body position) are performed on the subject, and baseline parameters are measured as in the baseline procedure. parameters as at baseline. Pre- and post-intervention comparisons will test the hypothesis that increased intrathoracic fluid content will increase the impedance value measured by EIT. Corresponding t-tests or Wilcoxon's signed rank sum test will be used for pre- and post-intervention comparisons of parameters, and correlation analysis will be used to examine the relationship between intrathoracic pressure (substituted by airway pressure due to the difficulty of directly measuring it) and impedance values.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
1. measurement will be performed in the anesthesiologist's office
2. The time required is about 1 hour (including breaks). (including a break)
3. recruitment of subjects will be open to the public.
4. recruitment will be open to healthy healthcare professionals and medical students. Recruitment will be open to healthy healthcare professionals and medical students, and recruitment information will be posted in the anesthesiologist's office and surrounding corridors.
5. a supine healthy adult will be fitted with an electrical impedance tomography (EIT) measurement belt;
6. a flow sensor will be connected to the EIT belt; 7. the EIT belt will be attached to the anesthesiologist's chest
A face mask with a flow sensor attached will be placed on the subject, and spontaneous breathing will be induced to simultaneously measure respiratory parameters such as airway pressure, flow rate, and ventilation rate, as well as impedance using EIT.
7. In the actual measurement procedure, the subject is first placed in the supine position and normal breathing is measured.
8. Next, after elevation of both lower extremities, the same measurements are taken.
9. Next, after both lower limbs have been raised, the patient is placed in the supine position and normal breathing is measured.
10. Next, while in the supine position, connect an external resistor with a 3 mm inner diameter slit to the end of the flow sensor and perform the same measurements.
11. Next, remove the external resistor and perform a normal breath measurement.
12. Then, while the patient is in the supine position, perform a normal breath measurement. Next, while in the supine position, connect an external resistor with a slit of 2 mm inner diameter to the end of the flow sensor and perform the same measurement.
13. Finally, the external resistor is disconnected and a normal breath is measured.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) ASA-PS (American Society of. Anesthesiologists physical status) 1 or 2.
(2) Persons who have given their written consent to participate in the study.
Key exclusion criteria
Patients with pre-existing respiratory disease.
Patients with pre-existing cardiovascular disease.
Patients with pre-existing neuromuscular disease.
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City
TEL
022-717-7321
yamauchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai City
TEL
022-717-7321
Homepage URL
takahashi.kazuhiro@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 23 | 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
11
Results
EIT data were obtained from all 11 participants.
Results date posted
| 2024 | Year | 12 | Month | 18 | Day |
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061917
