Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure

Completed

• Conditions: Heart Failure; Pleural Effusion

• Registration Number: NCT03189654
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

Brief Summary

There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. In view of the pathophysiological process with pleural effusion resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation might provide an improvement.

The aim of the present study is to investigate whether an additional non-invasive ventilation therapy leads to an improved suppression of pleural effusion in heart failure patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Study Start: 2017-07-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Patients admitted to our hospital on a routine or emergency basis
• Patients with heart failure according to the current ESC guidelines and chronic pleural effusion with clinical indication for pleurocentesis
• Non-invasively determined cardiac index of < 2.5 l/min/m²
• BNP > 300 pg/ml
• Transudative pleural effusion according to Light criteria
• Effective pleurocentesis with residual effusion on the side affected of < 500 ml
• Tolerance of non-invasive ventilation without subjective or objective hemodynamic impairment as verified during a test ventilation
• No change in drug or other therapy for the duration of the study (5 days)

Exclusion Criteria

• Psychological or neurological concomitant disease making an informed consent impossible
• Pregnancy
• Pneumothorax or pneumomediastinum
• Pathologically low blood pressure, particularly associated with intravascular volume depletion
• Liquor discharge, recent head surgery or trauma
• Severe bullous lung disease
• Dehydration
• Current ventilation therapy
• Bilateral pleural effusion > 500 ml at the time of enrolment
• Exudative pleural effusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of pleural effusion	5 days

Secondary Outcome Measures

Name	Time	Method
NYHA class	5 days
Cardiac output	5 days
nt-Pro-BNP	5 days

Trial Locations

Locations (1)

Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum; 🇩🇪 Bad Oeynhausen, Germany