Noninvasive Ventilation Clinical Trial
— RECAPTUREOfficial title:
Nocturnal Non-Invasive Ventilation in COPD Patients With Stable Hypercapnic Respiratory Failure: Why and in Which Patient Might This be Effective?
Verified date | November 2023 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 116 |
Est. completion date | November 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Indication to initiate chronic NIV in COPD patients (GOLD stage III or IV: FEV1/ forced expiratory volume (FVC)< 70% and FEV1< 50% predicted; PaCO2 > 6.0 kilopascal (kPa) in stable condition, which means no COPD exacerbation for 4 weeks and a pH > 7.35) - Age > 18 years - Written informed consent is obtained Exclusion Criteria: For the randomised Inflammation part a potential subject who meets any of the following criteria will be excluded from participation in this study: - Oral corticosteroids or roflumilast - A history of lung volume reduction surgery - Body mass index (BMI) > 35 kg/m2 - Obstructive sleep apnoea (OSA) (apnoea/hypopnea index (AHI) >15/hr): to exclude OSA a polygraphy will be done at baseline - PaCO2 = 8.0 kPa or PaO2 < 6.5 kPa at rest without oxygen - Instable cardiac comorbidities (left ventricular ejection fraction (LVEF) <40%, instable coronary artery disease, instable heart failure) |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
Peter Wijkstra |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FEV1 | Change in Forced expiratory volume in one second | baseline, 3 months | |
Primary | Health-Related Quality of Life | Change in HRQoL assessed by the severe respiratory insufficiency questionnaire summary score (SRI) | baseline, 3 months, 6 months | |
Secondary | Safety: the number of adverse events will be recorded. | The number of adverse events will be recorded. | baseline, 3 months, and 6 months | |
Secondary | Health-related quality of life assessed with the SF-36 | Additional assessment of generic and disease specific aspects of HRQoL, evaluated with the SF-36. | baseline, 3 months, 6 months | |
Secondary | Anxiety and depression | Anxiety and depression, evaluated by the hospital anxiety and depression scale (HADS). | baseline, 3 months, 6 months | |
Secondary | Activities and Restrictions, | Activities and Restrictions, assessed with the Groningen Activity and Restriction Scale (GARS). | baseline, 3 months, 6 months | |
Secondary | Caregiver Burden | Caregiver Burden, assessed with the Caregiver Strain Index (CSI) | baseline, 3 months, 6 months | |
Secondary | Dyspnoea | Dyspnoea, using the Medical Research Council (MRC) score. | baseline, 3 months, 6 months | |
Secondary | Gas exchange day | Gas exchange at daytime without additional oxygen assessed with an arterial blood gas analysis | baseline, 3 months, 6 months | |
Secondary | Gas exchange night | Gas exchange during the night assessed with transcutaneous CO2 measurements. | baseline, 3 months, 6 months | |
Secondary | Respiratory muscle activity | Respiratory muscle activity during the night and during NIV will be assessed with surface electromyography (EMG) | baseline, 3 months | |
Secondary | Spirometry | Spirometry will be used to assess forced expiratory volumes | baseline, 3 months, 6 months | |
Secondary | Exercise tolerance | Exercise tolerance assessed by the 6-minute walking distance. | baseline, 3 months, 6 months | |
Secondary | Peripheral muscle function | The 1-repetition maximum strength test will performed using a resistance weight-lifting machine | baseline, 3 months | |
Secondary | Compliance with the ventilator | Compliance will be read from the ventilator counter readings | baseline, 3 months, 6 months | |
Secondary | Venous blood | Venous samples will be obtained for analyses of inflammatory markers | Baseline, 3 months | |
Secondary | Urine albumin to Creatinine ratio | Urine portion for albumin and creatinine will be obtained to obtain the albumin to creatinine ratio | Baseline, 3 months | |
Secondary | Nasal epithelium markers of remodelling and repair | For detailed description see the airway brush markers. | Baseline, 3 months | |
Secondary | Airway abnormalities | Airway abnormalities will be assessed with a High Resolution computertomography (HRCT) scanning with in- and expiration. | Baseline, 3 months | |
Secondary | Airway inflammation and remodeling | Airway inflammation and remodeling assessed with bronchial brushes and washes and airway biopsies obtained through bronchoscopy. Several markers leading to one profile will be assessed | Baseline, 3 months | |
Secondary | HRQoL assessed with CCQ | Additional assessment of generic and disease specific aspects of HRQoL, evaluated with the Clinical COPD Questionnaire (CCQ). | Baseline, 3 months, 6 months | |
Secondary | Patient-ventilator asynchrony | Patient-ventilator asynchrony during the night and during NIV will be assessed by comparing surface electromyography (EMG) signals with ventilator pressure tracings | baseline, 3 months | |
Secondary | Lung volumes | Bodyplethysmography will be used to assess lung volumes | baseline, 3 months, 6 months | |
Secondary | Emphysema | The amount of emphysema and air-trapping assessed with a High Resolution computertomography (HRCT) scanning with in- and expiration, and captured into an emphysema score. | baseline, 3 months |
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