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

NCT ID: NCT02942134

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-05-31

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.

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.

Conditions

Obstructive Chronic Bronchitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Felix JF Herth

OTHER

Sponsor Role: lead

Responsible Party

Felix JF Herth

Prof. Dr. med. Felix JF Herth

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Felix FJ Herth, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical Director Thoraxklinik Heidelberg

Central Contacts

Mavi D Schellenberg, Dr.med.

Role: CONTACT

mavi.schellenberg@med.uni-heidelberg.de

00496221-3968027

Felix FJ Herth, Prof.

Role: CONTACT

felix.herth@med.uni-heidelberg.de

00496221-3961201

Other Identifiers

S-484/2016

Identifier Type: -

Identifier Source: org_study_id