UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057398 |
|---|---|
| Receipt number | R000065577 |
| Scientific Title | Evaluation of Ventilation Status by Mask Ventilation Using Electrical Impedance Tomography C |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/03/25 21:59:57 |
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Basic information
Public title
Evaluation of Ventilation Status by Mask Ventilation Using Electrical Impedance Tomography A
Acronym
Evaluation of Ventilation Status by Mask Ventilation Using Electrical Impedance Tomography B
Scientific Title
Evaluation of Ventilation Status by Mask Ventilation Using Electrical Impedance Tomography C
Scientific Title:Acronym
Evaluation of Ventilation Status by Mask Ventilation Using Electrical Impedance Tomography D
Region
| Japan |
Condition
Condition
Patients who are scheduled to undergo surgery under general anesthesia and have no obvious respiratory disease.
Classification by specialty
| Anesthesiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to observe and compare the changes in respiratory status during induction of anesthesia by comparing the expiratory end-expiratory lung volumes measured by electrical impedance tomography (EIT) during mask ventilation and spontaneous breathing before induction of anesthesia, and during mask ventilation and ventilation after introduction of a ventilator, respectively.The purpose of this study is to observe and compare the changes in respiratory status during induction of anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expiratory terminal lung volumes in electrical impedance tomography during spontaneous breathing and mask ventilation
Key secondary outcomes
Compliance changes in EIT during spontaneous breathing and mask ventilation.
Ventilation distribution by region of interest in EIT during spontaneous breathing and mask ventilation.
End-expiratory lung volumes during mask ventilation and ventilatory management after induction of anaesthesia.
Compliance changes during mask ventilation and ventilatory management after induction of anaesthesia.
Ventilation distribution by region of interest during mask ventilation and ventilatory management after induction of anaesthesia.
Other data that can be measured by EIT
Comparison of data between operators performing mask ventilation.
Factorial analysis of hyperventilation and hypoventilation (in this case, hypoventilation is defined as below ideal body weight x 6-8 mL/kg and hyperventilation as above ideal body weight).
Actual ventilator values
Blood pressure
Heart rate
SPO2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Disease name Subjects who are scheduled to undergo surgery under general anesthesia and have no obvious respiratory disease Stage, stage N/A Gender Male/Female Age 20 years old and over, 100 years old and under Those who can obtain consent from the patient himself/herself.
Key exclusion criteria
Patients with contraindications to EIT placement (patients with implantable cardioverter-defibrillators or pacemakers, patients with inflammation or wounds at the interface placement site, patients with spinal cord injury or fractures that pose a risk to the placement of the interface) Emergency surgery patients with obstructive or restrictive disorders (<70% 1 second rate orPercent lung capacity less than 80%) Patients with congestive heart failure NYHA III/IV
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | BAMBA |
Organization
Shiga University of Medical Science Hospital
Division name
Basic Nursing (Biochemistry, Pharmacology and Nutrition), School of Nursing, Faculty of Medicine
Zip code
520-2192
Address
Seta Tsukinawa-cho, Otsu City, Shiga Prefecture, Japan
TEL
077-548-2111
sb@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | NAKAGAWA |
Organization
Municipal Nagahama Hospital
Division name
central operating room
Zip code
526-8580
Address
313, Ohinui-cho, Nagahama City, Shiga Prefecture, Japan
TEL
0749-68-2300
Homepage URL
tbs283@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta Tsukinawa-cho, Otsu City, Shiga Prefecture, Japan
Tel
077-548-2111
sb@belle.shiga-med.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
| 2025 | Year | 07 | Month | 01 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The consent for participation in this study will be obtained in writing from the surgical patient undergoing general anesthesia the day before or before entering the operating room on the day of the surgery.Once the patient enters the operating room, an EIT belt will be placed at the 4th intercostal space before induction of anesthesia, and data collection will begin.Data at this point of spontaneous respiration will be used as baseline.After induction of anesthesia and administration of muscle relaxants, mask ventilation is performed, followed by intubation and ventilator management, and a series of data is collected by EIT.Airway pressure during mask ventilation and ventilator management are recorded when respiratory status is stabilized.
Management information
Registered date
| 2025 | Year | 03 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065577
