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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189654
• Other study ID #: HDZNRW-KA_010_TB
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: March 12, 2020

Study information

• Verified date: July 2020
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 12, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Pleural Effusion

Intervention

Device:
• Non-invasive ventilation
Non-invasive Ventilation for a Minimum of 8 h per day after pleurocentesis

Locations

Country	Name	City	State
Germany	Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum	Bad Oeynhausen

Sponsors (2)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia	ResMed GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of pleural effusion		5 days
Secondary	nt-Pro-BNP		5 days
Secondary	Cardiac output		5 days
Secondary	NYHA class		5 days