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Comparing a New Breathing Test Device with the Ventilator

Comparative Study of Airway Occlusion Pressure Measured Using a Digital Simplified Inspiratory Pressure Device and a Ventilator - AOP SIP Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057690
Enrollment
10
Registered
2025-04-28
Start date
2025-04-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult volunteers

Interventions

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 cons
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 su
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 ses

Sponsors

St.Marianna University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1, Healthy adult volunteers, regardless of sex. 2. Individuals who have provided written informed consent directly.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
The level of agreement in delta Pocc measurements between the RP check device and the mechanical ventilator

Secondary

MeasureTime frame
Correlation between delta Pocc measured during mechanical ventilation and diaphragmatic excursion and thickening fraction

Countries

Japan

Contacts

Public ContactTakuro Nakashima

St. Marianna University Hospital Department of emergency and critical care medicine

takuro.nakashima@marianna-u.ac.jp081-044-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026