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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03189654

Enrollment

Registered

2017-06-16

Start date

2017-07-01

Completion date

2020-03-12

Last updated

2020-07-30

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

Conditions

Heart Failure, Pleural Effusion

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.

Interventions

DEVICENon-invasive ventilation

Non-invasive Ventilation for a Minimum of 8 h per day after pleurocentesis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Amount of pleural effusion	5 days

Secondary

Measure	Time frame
nt-Pro-BNP	5 days
Cardiac output	5 days
NYHA class	5 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026