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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02585752

Acronym

ComfortCOPD

Enrollment

Registered

2015-10-23

Start date

2015-10-01

Completion date

2017-11-24

Last updated

2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

DEVICENoninvasive ventilation

Expiratory pressure modulation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Visual Analogue Scale	1 day	Subjective rating of comfort during expiration

Secondary

Measure	Time frame	Description
Minute ventilation	1 day	Volume of inhaled air in one minute (L/min)
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)
CO2 transcutaneous (tcCO2)	1 day	Arterial carbon dioxide partial pressure (mm Hg)
pO2 arterial (paO2)	1 day	Arterial oxygen partial pressure (mm Hg)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026