UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062852 |
|---|---|
| Receipt number | R000071954 |
| Scientific Title | Registry for Automated Mechanical VEntilation in Adults in Japan |
| Date of disclosure of the study information | 2026/09/09 |
| Last modified on | 2026/09/09 09:06:33 |
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Basic information
Public title
Registry for Automated Mechanical VEntilation in Adults in Japan
Acronym
RAVE-J
Scientific Title
Registry for Automated Mechanical VEntilation in Adults in Japan
Scientific Title:Acronym
RAVE-J
Region
| Japan |
Condition
Condition
Critically ill adult patients requiring high-flow nasal oxygen (HFNO), non-invasive ventilation (NIV), or invasive mechanical ventilation (IMV) during their ICU stay.
Classification by specialty
| Pneumology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the safety and performance of Hamilton Medical AG devices, including automated mechanical ventilation software packages, in critically ill adult patients admitted to the ICU, and to provide real-world evidence on their use in routine clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety: Percentage of time during automated HFNO, NIV, or IMV in which predefined ventilation parameters (tidal volume, maximum airway pressure, SpO2, PetCO2, respiratory rate, Pmax minus PEEP, driving pressure, and mechanical power, as applicable) are outside the predefined optimal and acceptable ranges.
Performance: Percentage of time during the observation period in which the same ventilation parameters remain within the predefined optimal ranges.
Key secondary outcomes
Incidence of adverse events and complications associated with automated HFNO, NIV and IMV, and occurrence of contraindications to automated ventilation software packages.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 18 years or older.
2. Patients who require high-flow nasal oxygen (HFNO), non-invasive ventilation (NIV), or invasive mechanical ventilation (IMV) at any time during their ICU stay.
Key exclusion criteria
1. Patients expected to be weaned from HFNO or NIV within 2 hours.
2. Patients expected to be weaned or extubated from IMV within 2 hours without requiring HFNO or NIV support.
3. Patients expected to be transferred to a non-participating ICU within 2 hours.
4. Patients expected to die within 2 hours.
5. Patients who refuse collection of clinical data.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Nakayama |
Organization
Jichi Medical University
Division name
Division of Intensive Care, Department of Anesthesiology and Intensive Care Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
TEL
0285-58-7392
m10077rn@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Nakayama |
Organization
Jichi Medical University
Division name
Division of Intensive Care, Department of Anesthesiology and Intensive Care Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
TEL
0285-58-7392
Homepage URL
m10077rn@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Ryuichi Nakayama
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamilton Medical AG
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Clinical Research Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
Tel
0285-58-8933
rinri@jichi.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT06655805
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 09 | 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 | 11 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study conducted at Jichi Medical University Hospital as the Japanese component of the international RAVE registry. Consecutive patients aged 18 years or older who require HFNO, NIV, or IMV during their ICU stay will be enrolled. No study-specific intervention is performed, and treatment decisions are made by the treating physicians according to routine clinical practice. Routinely collected demographic, severity, respiratory support, blood gas, and outcome data are recorded, together with high-resolution respiratory waveform data obtained using a Memory Box connected to the ventilator. Safety is evaluated as the percentage of time during automated ventilation in which predefined ventilation parameters are outside the optimal and acceptable ranges. Performance is evaluated as the percentage of time in which the same parameters remain within the optimal ranges. Adverse events, complications, and contraindications to automated ventilation software packages are also assessed. The Japanese study uses an opt-out approach. The target sample size in Japan is 120 patients.
Management information
Registered date
| 2026 | Year | 09 | Month | 09 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071954
