The objective of this multicenter observational study is to verify the clinical efficacy and utility of the javalla mask in non-invasive ventilation (NIV).
Conditions
Interventions
None listed
Sponsors
iDevice, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Individuals deemed unsuitable for study participation by the attending physician, principal investigator or co-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan,Asia(except Japan),Europe
Contacts
Public ContactMasatake Tamaki
The Japan Society of Clinical Reesarch Department of Clinical Investigation
Outcome results
None listed