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

Obstructive Chronic Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02942134
• Other study ID #: S-484/2016
• Status: Not yet recruiting
• Phase: N/A
• First received: October 20, 2016
• Last updated: October 20, 2016
• Start date: November 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2016
• Source: Heidelberg University
• Contact: Mavi D Schellenberg, Dr.med.
• Phone: 00496221-3968027
• Email: mavi.schellenberg[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Dyspnea
• Obstructive Chronic Bronchitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Felix JF Herth

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of acute dyspnea after use of non-invasive Ventilation in COPD and emphysema		May 2018	No