Acute Dyspnea After Use of Non-invasive Ventilation in COPD and Emphysema (Deventilation Syndrome)

October 20, 2016 updated by: Felix JF Herth

Acquisition and Evaluation of Augemented Dyspnea After Use of Non-invasive Ventilation in Patients With COPD and Empysema (Deventilation Syndrome)

Acute dyspnea after use of non-invasive ventilation (NIV) is a common phenomenon in patients with COPD and emphysema. This trial aims to document incidence and severity of augmented dyspnea in patients with long term NIV therapy. These findings may help in understanding the pathomechanisms that lead to post-NIV dyspnea and thus give way to potential therapy schemes.

Study Overview

Status

Unknown

Conditions

Detailed Description

Non-invasive ventilation (NIV) is a widespread therapy option for patients with hypercapnic failure due to COPD and emphysema. Augmented dyspnea after use of NIV is commonly found and leads not only to high patient discomfort, but can also be associated with acute respiratory failure. This monocentric obervation trial includes patients with COPD III°-IV° (GOLD) and emphysema and an established long term NIV therapy. During their routine inpatient follow-up, we will extend the routine examinations, focussing on the vulnerable first hour after the nocturnal use of NIV. This includes monitoring of breath rate, heart rate, pulsoxymetry, trancutaneous CO2, blood pressure and capillary blood gas analysis. Sonographic measurement of diaphragm movement and thickness will be complemented. Subjective dyspnea will be documented by use of the BORG scale.

By collecting this data, we hope to understand the pathomechanisms causing augmented dyspnea after NIV and thus provide information for therapeutical concepts to prevent it.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic hypercapnic failure due to COPD III to IV GOLD and emphysema on long term noninvasive ventilation

Description

Inclusion Criteria:

  • Males and females with stabile COPD, last exacerbation over one month,
  • GOLD III to IV
  • Regular use of noninvasive ventilation, more than four hours per day for more than one year
  • Signed declaration of consent
  • Sufficient language capabilities, german

Exclusion Criteria:

  • Acute exacerbation in the past four weeks
  • Acute pulmonary embolus
  • Haemoptysis
  • Severe neurological disease
  • Severe cardiological disease
  • Haemodynamic instability
  • New hypoxia or worsening of hypercapnia more than twenty percent of usual rate
  • Acute pneumothorax
  • Other instable Situation, for example intraabdominal bleedings
  • Drug or alcohol dependency
  • Regular intake of morphium
  • Adiposity BMI over 35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of acute dyspnea after use of non-invasive Ventilation in COPD and emphysema
Time Frame: May 2018
May 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Felix JF Herth

Investigators

  • Principal Investigator: Felix FJ Herth, Prof., Medical Director Thoraxklinik Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-484/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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