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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02942134

Enrollment

Registered

2016-10-21

Start date

2016-11-30

Completion date

2018-05-31

Last updated

2016-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Chronic Bronchitis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Contacts

Primary ContactMavi D Schellenberg, Dr.med.

mavi.schellenberg@med.uni-heidelberg.de00496221-3968027

Backup ContactFelix FJ Herth, Prof.

felix.herth@med.uni-heidelberg.de00496221-3961201

Outcome results