UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061911 |
|---|---|
| Receipt number | R000070483 |
| Scientific Title | A Prospective Observational Study Evaluating the Feasibility of VentOCR for Ventilator Waveform Analysis |
| Date of disclosure of the study information | 2026/06/19 |
| Last modified on | 2026/06/15 14:28:13 |
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Basic information
Public title
Feasibility Study of Ventilator Waveform Analysis Software (VentOCR)
Acronym
Feasibility Study of VentOCR
Scientific Title
A Prospective Observational Study Evaluating the Feasibility of VentOCR for Ventilator Waveform Analysis
Scientific Title:Acronym
Feasibility Study of VentOCR
Region
| Japan |
Condition
Condition
Respiratory failure requiring ventilator management in the intensive care unit
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify whether the waveform analysis software (VentOCR) can accurately extract the waveforms and numerical values displayed on the ventilator's graphic screen.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VentOCR Ventilator Graphic Monitor Reading Accuracy
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older who were placed on mechanical ventilation in the ICU
2. Cases in which mechanical ventilation was initiated using the Puritan Bennett980, SERVO-U, Hamilton C6, or Evita V600
(We decided to conduct the study using ventilators commonly used in the ICU.)
3. Patients expected to survive for at least 8 hours after initiation of mechanical ventilation
Key exclusion criteria
1. When ventilators or recording equipment were not available (due to a shortage of equipment)
2. The researcher was absent
3. Informed consent could not be obtained
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | YUSUKE |
| Middle name | |
| Last name | NAITO |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
schneider.yusuke@gmail.com
Public contact
Name of contact person
| 1st name | YUSUKE |
| Middle name | |
| Last name | NAITO |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
schneider.yusuke@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Medical Ethics Review Committee Secretariat
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-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
| 2026 | Year | 06 | Month | 19 | 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 | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070483
