The objective of this study is to verify the clinical efficacy and utility of the javalla mask in non-invasive ventilation (NIV).
Conditions
Interventions
Non-invasive ventilation using javalla
Non-invasive ventilation using masks other than javalla
Sponsors
iDevice, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
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) 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. | — |
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) 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. | — |
Countries
Japan,Asia(except Japan),Europe
Contacts
Public ContactMasatake Tamaki
The Japan Society of Clinical Reesarch Department of Clinical Investigation
Outcome results
None listed