UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056034 |
|---|---|
| Receipt number | R000064031 |
| Scientific Title | Clinical Optimization of Mask Fit and Oxygenation for Respiratory Therapy using javalla: Interventional Multicenter Prospective study for Advanced Care and Treatment |
| Date of disclosure of the study information | 2024/11/03 |
| Last modified on | 2024/11/06 14:09:59 |
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Basic information
Public title
Clinical Optimization of Mask Fit and Oxygenation for Respiratory Therapy using javalla: Interventional Multicenter Prospective study for Advanced Care and Treatment
Acronym
COMFORT-IMPACT Study
Scientific Title
Clinical Optimization of Mask Fit and Oxygenation for Respiratory Therapy using javalla: Interventional Multicenter Prospective study for Advanced Care and Treatment
Scientific Title:Acronym
COMFORT-IMPACT Study
Region
| Japan | Asia(except Japan) | Europe |
Condition
Condition
The objective of this 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 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)
Evaluation points will be set before NIV, during NIV (throughout the period or at specific points), and at various points after NIV (upon ICU discharge, at hospital discharge, or one month, three months, six months post-discharge or post-admission).
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)
Evaluation points will be set before NIV, during NIV (throughout the period or at specific points), and at various points after NIV (upon ICU discharge, at hospital discharge, or one month, three months, six months post-discharge or post-admission).
Other indices deemed necessary by researchers.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Non-invasive ventilation using javalla
Interventions/Control_2
Non-invasive ventilation using masks other than javalla
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
Inclusion criteria for this study are:
1. Patients eligible for non-invasive ventilation (NIV)
2. Healthy individuals (medical staff and the general public)
Specifically, in the emergency and intensive care fields, the focus is particularly on patients with acute respiratory failure based on chronic obstructive pulmonary disease or heart failure. In the field of cardiology, the emphasis is especially on patients with heart failure, while in surgery, the focus is on postoperative patients and those under perioperative management. In the field of respiratory diseases, the study targets patients with sleep apnea syndromes or those requiring respiratory support due to neuromuscular disorders. Additionally, in nursing, patients requiring care for pressure ulcers or wound management are included.
Key exclusion criteria
Individuals deemed unsuitable for study participation by the attending physician, principal investigator or co-investigators.
Target sample size
30
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
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=R000064031
