Non-Invasive Ventilation Clinical Trial
— VITABREATHOfficial title:
Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD
Verified date | October 2018 |
Source | Icadom |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 10, 2018 |
Est. primary completion date | January 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients with stable severe COPD (with FEV1 =50% predicted) - Patients with mMRC score > ou = 2. Exclusion Criteria: - Exacerbate within a month prior. - Using other non invasive ventilation device > 15h per day. - Have musculoskeletal or neuromuscular problem affecting balance and walking. - Have cognitive problem affecting comprehension of the different évaluations or questionnaires. - Have recently participated in physical training or rehabilitation program (= 3 months). - Medical contra-indication to NIV. - Evolutionary pathologies (excluding COPD) may be life-threatening in the short term (1 year) (cancer, neuromuscular disease rapidly changing). - Simultaneously enrolled in an other clinical trial. - Not affiliated to social security. - Person deprived of liberty, major protected by law. |
Country | Name | City | State |
---|---|---|---|
France | Dr Michèle Bognie Pneumology Office | Alès | |
France | Clinique du Parc | Castelnau-le-Lez | |
France | CHU Grenoble-Alpes | Grenoble | |
France | Hôpital Privé La Louvière | Lille | |
France | Dr Christian PAILLARGUELO Pneumology Office | Lunel | |
France | CHU Caremeau | Nîmes | |
France | Clinique Pasteur | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Icadom | Philips Respironics |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Compliance to the device | During a weekly phone call, patients will indicate the daily duration and conditions of use of the device | Every week over the 4-week period | |
Other | Number of acute exacerbation | Exacerbation is defined as changing the respiratory status of the patient relative to the patient's usual state, which requires acute hospitalisation. | Up to 12 months before the date of inclusion | |
Other | Weight | Patient will indicate their weight | baseline and post use of the Vitabreath device at 4th weeks | |
Primary | Change of daily physical activity measured by actimetry | Change of number of steps by day and daily energy expenditure over the 8 week period | Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device | |
Secondary | Change of Baseline Dyspnea Index (BDI) score | The BDI represents importance and impact of dyspnea in daily life of COPD patients. The BDI is one of dyspnea parameters (questionnaire). Three dimension questions include; 1.effect of daily function on dyspnea, 2. effect of magnitude of task on dyspnea and 3. effect of magnitude off effort on dyspnea. | baseline and post use of the Vitabreath device at 4th weeks | |
Secondary | Change of Modified Medical Research Council Questionnaire (mMRC) score | The mMRC is one of dyspnea parameters | baseline and post use of the Vitabreath device at 4th weeks | |
Secondary | Change of Transition Dyspnea Index (TDI) | The TDI assesses change of dyspnea perception from the BDI in each dimensions. Patient will rate score from -6 to +6 (positive score reflect improve of dyspnea and negative score reflect worse dyspnea). | baseline and post use of the Vitabreath device at 4th weeks | |
Secondary | Subjective appréciation of the device | Patients will rate their appreciation of the device using 3 scale relatives to ease of use, helps recovery shortness of breath, helps to be more active in daily life | post use of the Vitabreath device at 4th weeks | |
Secondary | Change of Visual Simplified Respiratory Questionnaire (VSRQ) score | The VRSQ represents health related quality of life of COPD patients | baseline and post use of the Vitabreath device at 4th weeks | |
Secondary | Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score | The CAT represents health related quality of life of COPD patients | Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05756387 -
Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach
|
||
Not yet recruiting |
NCT06259565 -
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
|
Phase 3 | |
Completed |
NCT02973373 -
MRI of the Chest Under High Frequency Ventilation
|
N/A | |
Recruiting |
NCT06072339 -
Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation (Opti-PEP).
|
N/A | |
Recruiting |
NCT04054622 -
Patient-ventilator Asychrony During Non-invasive Ventilation When COPD Patients Doing Exercise
|
||
Completed |
NCT03859947 -
High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis
|
||
Completed |
NCT03149835 -
NIV Reduces CBF in COPD Patients Without Cognitive Function
|
N/A | |
Recruiting |
NCT04036175 -
Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU.
|
N/A | |
Recruiting |
NCT02712190 -
Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.
|
N/A | |
Not yet recruiting |
NCT05435183 -
Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving Carbon Dioxide Clearance in AECOPD Patients
|
N/A | |
Recruiting |
NCT05796297 -
Clinical Impact of Patient-ventilator Asynchrony
|
||
Not yet recruiting |
NCT05850195 -
Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure
|
||
Not yet recruiting |
NCT05448417 -
Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects
|
N/A | |
Completed |
NCT05031650 -
Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room
|
N/A | |
Completed |
NCT04178694 -
The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers
|
N/A | |
Not yet recruiting |
NCT05721833 -
Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving CO2 Clearance in COPD Patients
|
N/A | |
Not yet recruiting |
NCT05706467 -
The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia
|
N/A | |
Recruiting |
NCT01961245 -
Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
|
N/A | |
Recruiting |
NCT03978221 -
Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period.
|
N/A | |
Completed |
NCT04884828 -
Asynchronies in NIV With External Gas
|