A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b

Study Overview
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Brief Summary
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Dynamic pulmonary hyperinflation (DH) and intrinsic positive end-expiratory pressure (PEEP) are well known problems in COPD patients with acute and chronic respiratory failure. Measurement of intrinsic PEEP level during both, invasive and non-invasive ventilation is of major importance since in some circumstances (e.g. during exercise or during exacerbations) it can significantly increase respiratory workload of COPD patients. Extrinsic PEEP applied during both, invasive and noninvasive ventilation is used to overcome intrinsic PEEP and therefore to avoid or reduce dynamic hyperinflation.

Official Title
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A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years who are contractually capable and mentally able to understand and follow the instructions of the study personnel Signed informed consent Moderate to severe COPD patients (FEV1/FVC ratio <70% and FEV1 < 50% pred) with chronic hypercapnic respiratory failure (PaCO2 >45 mmHg) Currently using NIV Exclusion Criteria: Acute exacerbation of COPD, acute respiratory failure (ph < 7,35 and/or respiratory rate >30/min) Unstable heart failure Cardiac failure with dehydration Pregnancy/breastfeeding women Pneumothorax/-mediastinum Increased risk of pneumothorax, pneumomediastinum or venous air embolism In the opinion of the investigator, the patient is unsuitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single centre, single arm<br>Noninvasive ventilation with expiratory modulation. Assessment of comfort and blood gases. | Device: Noninvasive ventilation<br>* Expiratory pressure modulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Subjective rating of comfort during expiration | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minute ventilation | Volume of inhaled air in one minute (L/min) | 1 day | 
| Respiratory rate | Number of breaths per minute (breaths/min) | 1 day | 
| Tidal volume | Volume of air that is inhaled or exhaled during normal breathing (mL) | 1 day | 
| CO2 transcutaneous (tcCO2) | Arterial carbon dioxide partial pressure (mm Hg) | 1 day | 
| pO2 arterial (paO2) | Arterial oxygen partial pressure (mm Hg) | 1 day |