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OpenTrials
Completed

NCT Number: NCT03189654

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

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.

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Key information

Conditions

Pleural Effusion Cardiovascular Diseases Heart Diseases Heart Failure Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive ventilation

Device

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

Primary outcomes

  1. Amount of pleural effusion

    Time frame: 5 days

Secondary outcomes

  1. nt-Pro-BNP

    Time frame: 5 days

  2. Cardiac output

    Time frame: 5 days

  3. NYHA class

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Collaborators

  • ResMed GmbH & Co KG

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 16, 2017
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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