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

NCT02942134 | Unknown

• 1 other identifier: S-484/2016
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of acute dyspnea after use of non-invasive Ventilation in COPD and emphysema

  May 2018

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Felix JF Herth: lead

Study Officials

• Felix FJ Herth, Prof.

  Medical Director Thoraxklinik Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mavi D Schellenberg, Dr.med.

CONTACT

00496221-3968027; mavi.schellenberg@med.uni-heidelberg.de

Felix FJ Herth, Prof.

CONTACT

00496221-3961201; felix.herth@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Felix JF Herth

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 21, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: May 1, 2018
• Last Updated: October 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share