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

NCT ID: NCT02585752

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2017-11-24

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single centre, single arm

Noninvasive ventilation with expiratory modulation. Assessment of comfort and blood gases.

Group Type: EXPERIMENTAL

Noninvasive ventilation

Intervention Type: DEVICE

Expiratory pressure modulation

Interventions

Noninvasive ventilation

Expiratory pressure modulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Dreher, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Aachen

Locations

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

References

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

Reference Type: BACKGROUND

Other Identifiers

14-177 / AA-CmfCOPD-02

Identifier Type: -

Identifier Source: org_study_id