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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Noninvasive ventilation
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universitätsklinikum Aachen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single centre, single arm

Arm Description

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

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Subjective rating of comfort during expiration

Secondary Outcome Measures

Minute ventilation
Volume of inhaled air in one minute (L/min)
Respiratory rate
Number of breaths per minute (breaths/min)
Tidal volume
Volume of air that is inhaled or exhaled during normal breathing (mL)
CO2 transcutaneous (tcCO2)
Arterial carbon dioxide partial pressure (mm Hg)
pO2 arterial (paO2)
Arterial oxygen partial pressure (mm Hg)

Full Information

First Posted
October 20, 2015
Last Updated
April 19, 2018
Sponsor
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT02585752
Brief Title
A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b
Acronym
ComfortCOPD
Official Title
A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
November 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single centre, single arm
Arm Type
Experimental
Arm Description
Noninvasive ventilation with expiratory modulation. Assessment of comfort and blood gases.
Intervention Type
Device
Intervention Name(s)
Noninvasive ventilation
Intervention Description
Expiratory pressure modulation
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Subjective rating of comfort during expiration
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Minute ventilation
Description
Volume of inhaled air in one minute (L/min)
Time Frame
1 day
Title
Respiratory rate
Description
Number of breaths per minute (breaths/min)
Time Frame
1 day
Title
Tidal volume
Description
Volume of air that is inhaled or exhaled during normal breathing (mL)
Time Frame
1 day
Title
CO2 transcutaneous (tcCO2)
Description
Arterial carbon dioxide partial pressure (mm Hg)
Time Frame
1 day
Title
pO2 arterial (paO2)
Description
Arterial oxygen partial pressure (mm Hg)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dreher, MD
Organizational Affiliation
Universitätsklinikum Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Aachen
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
Cornelissen CG, Müller T, Schmitz S, Dreher M. Nichtinvasive Beatmung: Patientenkomfort und Sicherheit einer Modulation des expiratorischen Flusses. Pneumologie 2018; 72(S01), S11
Results Reference
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A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b

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