UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062141 |
|---|---|
| Receipt number | R000071112 |
| Scientific Title | Non-clinical performance evaluation of a novel respiratory support device integrating high-flow nasal cannula and CPAP using a 3D-printed airway model and a TTL lung model: a bench study |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/05 22:21:26 |
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Basic information
Public title
Bench evaluation of a novel respiratory support device combining high-flow nasal cannula and CPAP
Acronym
HFNC-P Bench Study
Scientific Title
Non-clinical performance evaluation of a novel respiratory support device integrating high-flow nasal cannula and CPAP using a 3D-printed airway model and a TTL lung model: a bench study
Scientific Title:Acronym
HFNC-P Bench Study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the performance of HFNC-P, a novel respiratory support device that integrates high-flow nasal cannula and CPAP, through bench experiments using a 3D-printed airway model and a TTL lung model.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
measured intratracheal PEEP
Key secondary outcomes
Difference between the set PEEP and the measured intratracheal PEEP
ETCO2 or PETCO2
Reduction in ETCO2 or PETCO2 from baseline
Mask pressure
Difference between intratracheal pressure and mask pressure
Mean PEEP
Minimum PEEP
Maximum PEEP
PEEP maintenance rate
Pressure drop during the inspiratory phase
Stability of the pressure waveform
Degree of PEEP increase associated with changes in flow rate
Degree of ETCO2 or PETCO2 reduction associated with changes in flow rate
FiO2 maintenance effect
Amount or presence of leakage
Humidification effect
Temperature inside the mask
Relative humidity or absolute humidity
Presence or absence of condensation or water droplet accumulation
Stability of CO2 supply
Stability of the ETCO2 waveform
Operation status of the safety valve or one-way valve
Pressure changes under abnormal conditions, such as obstruction, overpressure, or flow interruption
Performance differences between controlled ventilation and spontaneous breathing models
Performance differences among normal, restrictive, and obstructive lung models
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Not applicable
Key exclusion criteria
Not applicable
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Ryuto |
| Middle name | |
| Last name | Yokoyama |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Emergency Medicine
Zip code
990-9585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
0236331122
ryusi0311@gmail.com
Public contact
Name of contact person
| 1st name | RYUTO |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Emergency Medicine
Zip code
9909585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285422
Homepage URL
ryusi0311@gmail.com
Sponsor or person
Institute
Yamagata Univercity
Institute
Department
Personal name
RYUTO YOKOYAMA
Funding Source
Organization
Yamagata Univercity
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 Review Committee, Faculty of Medicine, Yamagata University
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
Tel
0236331122
ryusi0311@gmail.com
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
| 2026 | Year | 07 | Month | 06 | 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
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a non-clinical bench study with no human participants enrolled. The performance of a novel respiratory support device integrating high-flow nasal cannula and CPAP will be evaluated using a 3D-printed airway model and a TTL lung model. The investigational prototype will not be applied to or used in patients or healthy volunteers. The results of this study will not directly demonstrate efficacy or safety in humans, but will serve as preclinical performance data to support future first-in-human and patient-based clinical studies.
Management information
Registered date
| 2026 | Year | 07 | Month | 05 | Day |
Last modified on
| 2026 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071112
