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

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Noninvasive ventilation

• Registration Number: NCT02585752
• Lead Sponsor: ResMed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2017-09-30
• Study Completion: 2017-11-24
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age > 18 years who are contractually capable and mentally able to understand and follow the instructions of the study personnel
2. Signed informed consent
3. Moderate to severe COPD patients (FEV1/FVC ratio <70% and FEV1 < 50% pred) with chronic hypercapnic respiratory failure (PaCO2 >45 mmHg)
4. Currently using NIV

Exclusion Criteria

1. Acute exacerbation of COPD, acute respiratory failure (ph < 7,35 and/or respiratory rate >30/min)
2. Unstable heart failure
3. Cardiac failure with dehydration
4. Pregnancy/breastfeeding women
5. Pneumothorax/-mediastinum
6. Increased risk of pneumothorax, pneumomediastinum or venous air embolism
7. In the opinion of the investigator, the patient is unsuitable for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single centre, single arm	Noninvasive ventilation	Noninvasive ventilation with expiratory modulation. Assessment of comfort and blood gases.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	1 day	Subjective rating of comfort during expiration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum Aachen; 🇩🇪 Aachen, Nordrhein-Westfalen, Germany