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

Chronic Obstructive Pulmonary Disease Clinical Trial

— ComfortCOPD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02585752
• Other study ID #: 14-177 / AA-CmfCOPD-02
• Status: Terminated
• Phase: N/A
• First received: October 20, 2015
• Last updated: April 19, 2018
• Start date: October 1, 2015
• Est. completion date: November 24, 2017

Study information

• Verified date: April 2018
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 24, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Noninvasive ventilation
Expiratory pressure modulation

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	Subjective rating of comfort during expiration	1 day
Secondary	Minute ventilation	Volume of inhaled air in one minute (L/min)	1 day
Secondary	Respiratory rate	Number of breaths per minute (breaths/min)	1 day
Secondary	Tidal volume	Volume of air that is inhaled or exhaled during normal breathing (mL)	1 day
Secondary	CO2 transcutaneous (tcCO2)	Arterial carbon dioxide partial pressure (mm Hg)	1 day
Secondary	pO2 arterial (paO2)	Arterial oxygen partial pressure (mm Hg)	1 day