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Non-invasive ventilation (NIV) has shown to be an effective therapy for patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Hypercapnic Respiratory Failure (CHRF). However, these COPD patients often report severe dyspnoea after switching off from NIV therapy, which leads to discomfort and distress. Currently, it is not known what causes this deventilation dyspnoea and therefore a possible treatment to prevent deventilation dyspnoea is not available. This study investigates possible mechanisms underlying the phenomenon of deventilation dyspnoea in COPD patients by monitoring the effects of NIV on the patient during an afternoon sleep.
Rationale: Non-invasive ventilation (NIV) has shown to be an effective therapy for patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Hypercapnic Respiratory Failure (CHRF). However, these COPD patients often report severe dyspnoea after switching off from NIV therapy, which leads to discomfort and distress. Currently, it is not known what causes this deventilation dyspnoea and therefore a possible treatment to prevent deventilation dyspnoea is not available.
Objective: 1) To investigate what mechanisms underlie the phenomenon of deventilation dyspnoea in COPD patients. 2) To investigate how the change in electrical impedance, measured with electrical impedance tomography (EIT), is related to the change in inspiratory capacity (IC) before and after sleep.
Study design: This study is an observational cohort study analysing changes occurring due to NIV which could explain the existence of deventilation dyspnoea in certain COPD patients using NIV. Ten patients with and ten patients without deventilation dyspnoea will visit the hospital for an afternoon sleep, during and after which several non-invasive measurements are performed to analyse the changes occurring during and after switching off NIV. In order to investigate the deventilation problem, we will measure:
Study population: Twenty severe COPD patients (age>18yr) using chronic NIV will be included in the study: 10 patients with severe symptoms of deventilation dyspnoea (Borg Dyspnoea Scale ≥ 5) and 10 patients without symptoms of deventilation dyspnoea, matched with regard to the degree of static lung hyperinflation and NIV settings.
Main study parameters/endpoints: Knowledge about the changes occurring during NIV in patients with COPD with deventilation dyspnoea. The percent change in EELV, IC, respiratory muscle activity and PtcCO2 will be calculated for both groups and correlated with the degree of deventilation dyspnoea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients with deventilation dyspnoea | Ten severe COPD patients (age>18yr) using chronic NIV with severe symptoms of deventilation dyspnoea (Borg Dyspnoea Scale ≥ 5) |
| |
| COPD patients without deventilation dyspnoea | Ten severe COPD patients (age>18yr) using chronic NIV without symptoms of deventilation dyspnoea, matched with the first cohort/group with regard to the degree of static lung hyperinflation and NIV settings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements. | Device | Both groups get the same exposures: with measure physiology in both groups by using non-invasive measurement techniques. The techniques we use are Electrical Impedance Tomography to determine degree of hyperinflation. We use Electromyography to analyse respiratory drive. We measure transcutaneous carbon dioxide to assess the effects of non-invasive ventilation. Thereby, we will perform lung function tests. |
| Measure | Description | Time Frame |
|---|---|---|
| End-expiratory lung volume | The change in end-expiratory lung volume due to NIV-usage | Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep. |
| Inspiratory capacity | The change in inspiratory capacity due to NIV-usage | Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep. |
| Respiratory muscle activity | The change in respiratory muscle activity due to NIV-usage | Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep. |
| Transcutaneous carbon dioxide | The change in transcutaneous carbon dioxide due to NIV-usage | Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of inspiratory capacity with end-expiratory lung volume | To validate Electrical Impedance Tomography measurements to determine end-expiratory lung volume, we will compare these outcomes with the golden standard inspiratory capacity. | Through study completion, which is one day of NIV use. Compare the primary outcome before and after the afternoon sleep. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from the University Medical Center Groningen (UMCG). There is a large population of COPD patients using NIV known at the Home Mechanical Ventilation (HMV) Centre (around 120 patients). The pulmonologists know already at least 10 patients who suffer extremely from deventilation dyspnoea, which could possibly participate in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonary diseases | Groningen | Netherlands |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D004576 | Electromyography |
| ID | Term |
|---|---|
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009213 | Myography |
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|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |