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

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ClinicalTrials.gov Identifier: NCT02942134
Recruitment Status : Not yet recruiting
First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Felix JF Herth, Heidelberg University

Brief Summary:
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.

Condition or disease
Obstructive Chronic Bronchitis

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
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acquisition and Evaluation of Augemented Dyspnea After Use of Non-invasive Ventilation in Patients With COPD and Empysema (Deventilation Syndrome)
Study Start Date : November 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Incidence and severity of acute dyspnea after use of non-invasive Ventilation in COPD and emphysema [ Time Frame: May 2018 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942134


Contacts
Contact: Mavi D Schellenberg, Dr.med. 00496221-3968027 mavi.schellenberg@med.uni-heidelberg.de
Contact: Felix FJ Herth, Prof. 00496221-3961201 felix.herth@med.uni-heidelberg.de

Sponsors and Collaborators
Felix JF Herth
Investigators
Principal Investigator: Felix FJ Herth, Prof. Medical Director Thoraxklinik Heidelberg

Responsible Party: Felix JF Herth, Prof. Dr. med. Felix JF Herth, Heidelberg University
ClinicalTrials.gov Identifier: NCT02942134     History of Changes
Other Study ID Numbers: S-484/2016
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dyspnea
Bronchitis
Bronchitis, Chronic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive