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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Noninvasive ventilation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Universitätsklinikum Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Michael Dreher, MD, Universitätsklinikum Aachen

Publications and helpful links

General Publications

• Cornelissen CG, Müller T, Schmitz S, Dreher M. Nichtinvasive Beatmung: Patientenkomfort und Sicherheit einer Modulation des expiratorischen Flusses. Pneumologie 2018; 72(S01), S11

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): November 24, 2017

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 14-177 / AA-CmfCOPD-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No