UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057690 |
|---|---|
| Receipt number | R000065900 |
| Scientific Title | Comparative Study of Airway Occlusion Pressure Measured Using a Digital Simplified Inspiratory Pressure Device and a Ventilator |
| Date of disclosure of the study information | 2025/04/28 |
| Last modified on | 2026/04/24 10:27:24 |
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Basic information
Public title
Comparing a New Breathing Test Device with the Ventilator
Acronym
A-SIP Study (Assessment of Simplified Inspiratory Pressure Study)
Scientific Title
Comparative Study of Airway Occlusion Pressure Measured Using a Digital Simplified Inspiratory Pressure Device and a Ventilator
Scientific Title:Acronym
AOP SIP Study
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare airway occlusion pressure (Delta Pocc) measured using a mechanical ventilator and using the RP check device, and to evaluate the agreement between the two measurements.
Basic objectives2
Others
Basic objectives -Others
In healthy adult volunteers, diaphragmatic ultrasound findings (including diaphragmatic excursion and thickening fraction) will be measured along with airway occlusion pressure ( delta Pocc) using both the RP check device and a mechanical ventilator. The agreement among these measurements will be evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The level of agreement in delta Pocc measurements between the RP check device and the mechanical ventilator
Key secondary outcomes
Correlation between delta Pocc measured during mechanical ventilation and diaphragmatic excursion and thickening fraction
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1 Measurement Timing
delta Pocc will be measured promptly after enrollment using both a mechanical ventilator and the RPcheck device.
2 Repetition and Order
Each method will be used for five consecutive measurements. The order will be randomized.
3 RPcheck Measurement
Position: Supine with 30 degree head elevation
Equipment: Disposable oronasal mask and HME filter
Procedure: Subjects perform maximal inspiratory efforts; delta Pocc measured five times with 2minute intervals
4 Ventilator Measurement
Device: Puritan Bennette ventilator
Protocol: Same as RPcheck
5 Diaphragm Ultrasound
Excursion: Convex probe subcostally along midclavicular line; M mode during maximal inspiration
Thickening Fraction: Linear probe at right 8th 9th intercostal space, M mode during maximal inspiration
6 Total Time
All assessments will be completed in one session 15 minutes
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Healthy adult volunteers, regardless of sex.
2. Individuals who have provided written informed consent directly.
Key exclusion criteria
1. Individuals who do not provide informed consent.
2. Individuals with a history of lung or diaphragmatic surgery, or those with underlying pulmonary diseases currently requiring treatment (e.g., asthma).
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Nakashima |
Organization
St. Marianna University Hospital
Division name
Department of emergency and critical care medicine
Zip code
216-8511
Address
Sugao2-16-1, Miyamae ward, Kawasaki city, Kanagawa, Japan
TEL
081-044-977-8111
takuro.nakashima@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Nakashima |
Organization
St. Marianna University Hospital
Division name
Department of emergency and critical care medicine
Zip code
216-8511
Address
Sugao2-16-1, Miyamae ward, Kawasaki city, Kanagawa, Japan
TEL
081-044-977-8111
Homepage URL
takuro.nakashima@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University Hospital
Institute
Department
Personal name
Takuro Nakashima
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Research Promotion Division, Graduate School, St. Marianna University School of Medicine Hospital
Address
Sugao2-16-1, Miyamae ward, Kawasaki city, Kanagawa, Japan
Tel
081-044-977-8111
soumu@marianna-u.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 | 04 | Month | 28 | 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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2026 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065900
