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

NCT02585752 | Terminated

• 1 other identifier: 14-177 / AA-CmfCOPD-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  Subjective rating of comfort during expiration

  1 day

Secondary Outcomes (5)

• Minute ventilation

  1 day

• Respiratory rate

  1 day

• Tidal volume

  1 day

• CO2 transcutaneous (tcCO2)

  1 day

• pO2 arterial (paO2)

  1 day

Study Arms (1)

Single centre, single arm

EXPERIMENTAL

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

Device: Noninvasive ventilation

Interventions

Noninvasive ventilation DEVICE

Expiratory pressure modulation

Single centre, single arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related 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

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Michael Dreher, MD

  Universitätsklinikum Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 23, 2015
• Study Start: October 1, 2015
• Primary Completion: September 30, 2017
• Study Completion: November 24, 2017
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

DE (1)