Noninvasive Ventilation Clinical Trial
Official title:
Nocturnal Non-Invasive Ventilation in COPD Patients With Stable Hypercapnic Respiratory Failure: Why and in Which Patient Might This be Effective?
Rationale: Application of long-term non-invasive ventilation (NIV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve outcomes. However, the mechanism behind these improvements are unknown. We hypothesize that NIV stabilizes FEV1 via beneficial effects on inflammation and repair pathways in patients with COPD. In the present study we aim to investigate, in COPD patients with CHRF, 1. change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPD patients as compared to standard care 2. the relationship between FEV1 change and modification of systemic and airway inflammation and remodelling, lung hyperinflation, and airway morphology. 3. predictors of a favourable response to chronic NIV in COPD patients with CHRF. Study design: multicentre randomised controlled study investigating the effects of NIV on airway morphology, airway inflammation and remodelling in hypercapnic COPD patients including a control group that will postpone the initiation of NIV for 3 months. In addition we will investigate how patient demographics, patient and disease characteristics and systemic and airway inflammation predict the response to chronic NIV in severe stable COPD. To do this, all patients will be followed for 6 months after NIV initiation. Main study parameters/endpoints: The main endpoint is the change FEV1 after 3 months. Furthermore, as we recognise that FEV1 might not be the most important patient-related outcome, we will assess which parameters affect health-related quality of life after 3 and 6 months.
Rationale: Application of long-term non-invasive ventilation (NIV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve outcomes when applied with sufficiently high inspiratory pressures and adequate backup breathing frequencies (high-intensity NIV). Interestingly, it has been demonstrated that nocturnal NIV improves not only clinical but also physiological parameters like arterial carbon dioxide pressure (PaCO¬2¬) and forced expiratory volume in 1 second (FEV1) in patients with stable COPD. However, the mechanism behind these improvements are unknown. Furthermore, it is unclear whether this improvement in lung function influences health-related quality of life (HRQoL), the utmost goal of chronic NIV in COPD, or that other baseline patient- and ventilatory characteristics are more important in predicting a long-term beneficial effect. We hypothesize that NIV stabilizes FEV1 via beneficial effects on inflammation and repair pathways in the airways of patients with COPD. We aim to study this hypothesis and to investigate the regulation of lung function, markers of inflammation and repair pathways in airway biopsies, bronchial wash and bronchial and nasal epithelium in response to home mechanical ventilation. The second goal of this study is to define a phenotype of patients with COPD, based on baseline characteristics and biomarkers, such as markers of inflammation, who will respond to NIV therapy with improvements in lung function and HRQoL. Objectives: 1. To investigate change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPd patients as compared to standard care 2. To investigate the relationship between FEV1 change and modification of systemic and airway inflammation and remodelling, lung hyperinflation, and airway morphology. 3. To investigate predictors of a favourable response to chronic NIV in COPD patients with CHRF. Study design: The study is multicentre randomised controlled study investigating the effects of NIV on airway morphology, airway inflammation and remodelling in hypercapnic COPD patients including a control group that will postpone the initiation of NIV for 3 months. To measure these parameters a bronchoscopy with a bronchial wash and bronchial biopsies and high-resolution CT-scanning we be done at baseline and after 3 months. In a addition we will investigate how patient demographics, patient and disease characteristics and systemic and airway inflammation predict the response to chronic NIV in severe stable COPD. To do this, all COPD patients initiated on NIV in our centre will be followed for 6 months after NIV initiation as part of the present study. Study population: Patients who have an indication for NIV (COPD Global Initiative of Obstructive Lung Disease (GOLD) III or IV and a PaCO2 > 6.0 kilopascal (kPa) in stable disease) in the Netherlands will be asked to participate. For investigating airway inflammation, to ensure safety during the bronchoscopies, patients with severe gas exchange derangements (i.e. PaCO2 > 8.0 kPa and /or partial arterial oxygen pressure (PaO2)<6.5 kPa at rest during spontaneous breathing), and instable cardiac comorbidities will be excluded. These patients will be included to be followed for 6 months prospectively after NIV initiation, according to the same protocol, however, without CT-scanning and bronchoscopies. Main study parameters/endpoints: The main endpoint is the change FEV1 after 3 months. Several markers of blood and airway inflammation and remodeling will be assessed to analyse mechanisms of FEV1 improvements. Furthermore, as we recognise that FEV1 might not be the most important patient-related outcome, we will assess which parameters affect health-related quality of life after 3 and 6 months. For this, parameters of the total group of patients will be used. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02845076 -
Weaning From Noninvasive Ventilation
|
N/A | |
Recruiting |
NCT05008211 -
Information-Motivation-Behavioral Skills Model-based Intervention to Domiciliary Non-invasive Ventilation of Patients
|
N/A | |
Completed |
NCT03250416 -
Management of Noninvasive Ventilation in Hypoxemic Patients
|
||
Not yet recruiting |
NCT03687385 -
The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients
|
N/A | |
Not yet recruiting |
NCT03687424 -
Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults?
|
N/A | |
Recruiting |
NCT01791335 -
NIV and Glottis-diaphragm Synchrony
|
N/A | |
Recruiting |
NCT04165382 -
Development, Implementation and Evaluation of a Clinical Practice Guideline for Care of Preterm Infants Receiving Non-invasive Ventilation (NIV)
|
N/A | |
Completed |
NCT04912544 -
Facilitating Patient Communication During Noninvasive Ventilation
|
N/A | |
Active, not recruiting |
NCT03499470 -
Structured Discharge and Follow-up Protocol for COPD Patients Receiving LTOT and NIV
|
N/A | |
Not yet recruiting |
NCT05964244 -
Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure
|
N/A | |
Terminated |
NCT04413643 -
NIV for COPD: Hospital to Home
|
N/A | |
Completed |
NCT03151317 -
Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home CPAP or At-home NIV
|
||
Completed |
NCT03607357 -
High Flow Nasal Oxygen and Acute Left Heart Failure
|
N/A | |
Withdrawn |
NCT02615834 -
Chest Pressure for Intubated Peds Patients
|
N/A | |
Not yet recruiting |
NCT02383719 -
Mask Comfort Feasibility
|
N/A | |
Not yet recruiting |
NCT06260202 -
Nutrition Under Noninvasive Ventilation
|
||
Completed |
NCT03876873 -
Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults
|
N/A | |
Completed |
NCT02267291 -
Impact of Non-invasive Positive Pressure Ventilation on Cardiac Function and Echocardiographic Parameters
|
N/A | |
Not yet recruiting |
NCT04904484 -
A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients
|
N/A | |
Completed |
NCT03203577 -
Initiation of Home Mechanical Ventilation at Home in Patients With Chronic Hypercapnic Respiratory Failure
|
N/A |