UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056033 |
|---|---|
| Receipt number | R000064036 |
| Scientific Title | Clinical Optimization of Mask Fit and Oxygenation for Respiratory Therapy using javalla: IN-depth Study InteGrating multicenter observational Healthcare Therapeutic data |
| Date of disclosure of the study information | 2024/11/03 |
| Last modified on | 2024/11/06 14:10:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical Optimization of Mask Fit and Oxygenation for Respiratory Therapy using javalla: IN-depth Study InteGrating multicenter observational Healthcare Therapeutic data
Acronym
COMFORT-INSIGHT Study
Scientific Title
Clinical Optimization of Mask Fit and Oxygenation for Respiratory Therapy using javalla: IN-depth Study InteGrating multicenter observational Healthcare Therapeutic data
Scientific Title:Acronym
COMFORT-INSIGHT Study
Region
| Japan | Asia(except Japan) | Europe |
Condition
Condition
The objective of this multicenter observational study is to verify the clinical efficacy and utility of the javalla mask in non-invasive ventilation (NIV).
Classification by specialty
| Cardiology | Pneumology | Emergency medicine |
| Intensive care medicine | Nursing | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this multicenter observational study is to verify the clinical efficacy and utility of the javalla mask in non-invasive ventilation (NIV).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoints will be predetermined and selected from the following hard and soft endpoints based on the specific disease, patient characteristics, or clinical situation under investigation:
-Hard Endpoints-
Mortality (inpatient, outpatient)
Recurrence rate of acute respiratory failure (inpatient, outpatient)
Preventive effect on the occurrence of pressure ulcers
Therapeutic effect following the onset of pressure ulcers
-Soft Endpoints-
Measurement of air leak volume
Degree of improvement in respiratory indices and oxygenation
Tolerance of the mask (duration, frequency)
Comfort level (evaluated using the Visual Analogue Scale or Likert scale)
Time to mask fitting (benefit of one-size)
Frequency of agitation and leak alarms
Comparative measurement of skin pressure
Length of hospital stay, ICU management days (hours)
Health economic indicators (medical costs)
Data collection points will be designated before NIV, during NIV (throughout the period or at specified intervals), and at selected points after NIV, such as upon ICU discharge, at hospital discharge, or one month, three months, and six months post-discharge or post-admission, as dictated by the study objectives.
Other indices deemed necessary by researchers.
Key secondary outcomes
Secondary endpoints will also be predetermined and selected from the following hard and soft endpoints based on the specific disease, patient characteristics, or clinical situation under investigation:
-Hard Endpoints-
Mortality (inpatient, outpatient)
Recurrence rate of acute respiratory failure (inpatient, outpatient)
Preventive effect on the occurrence of pressure ulcers
Therapeutic effect following the onset of pressure ulcers
-Soft Endpoints-
Measurement of air leak volume
Degree of improvement in respiratory indices and oxygenation
Tolerance of the mask (duration, frequency)
Comfort level (evaluated using the Visual Analogue Scale or Likert scale)
Time to mask fitting (benefit of one-size)
Frequency of agitation and leak alarms
Comparative measurement of skin pressure
Length of hospital stay, ICU management days (hours)
Health economic indicators (medical costs)
Data collection points will be designated before NIV, during NIV (throughout the period or at specified intervals), and at selected points after NIV, such as upon ICU discharge, at hospital discharge, or one month, three months, and six months post-discharge or post-admission, as dictated by the study objectives.
Other indices deemed necessary by researchers.
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
| 6 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for the study are as follows:
1) Patients who have undergone NIV using the javalla mask and for whom the targeted obervational data are available.
2) Patients who have undergone NIV using masks other than javalla and for whom the targeted observational data are available.
Key exclusion criteria
Individuals deemed unsuitable for study participation by the attending physician, principal investigator or co-investigators.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Hara |
Organization
iDevice, Inc.
Division name
Department of Medical Device Development
Zip code
530-0001
Address
1-11-4-1000 Umeda, Kita-ku, Osaka city
TEL
+81-6-7178-3590
hara@med-idevice.com
Public contact
Name of contact person
| 1st name | Masatake |
| Middle name | |
| Last name | Tamaki |
Organization
The Japan Society of Clinical Reesarch
Division name
Department of Clinical Investigation
Zip code
561-0871
Address
Higashiterauchi-cho 1-10-446, Toyonaka, Osaka
TEL
81-90-7593-2229
Homepage URL
info@japanscr.org
Sponsor or person
Institute
iDevice, Inc.
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Ethical Comittee of the Japan Society of Clinical Research
Address
Higashiterauchi-cho 1-10-446, Toyonaka, Osaka
Tel
81-90-7593-2229
info@japanscr.org
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
| 2024 | Year | 11 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 12 | Month | 31 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2024 | Year | 11 | Month | 03 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064036
