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

July 29, 2020 updated by: Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with decompensated heart failure and pleural effusion

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group
Non-invasive ventilation after pleurocentesis
Device: Non-invasive ventilation
Non-invasive Ventilation for a Minimum of 8 h per day after pleurocentesis
Control group
Oxygen Administration via nasal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of pleural effusion
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
nt-Pro-BNP
Time Frame: 5 days
5 days
Cardiac output
Time Frame: 5 days
5 days
NYHA class
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Collaborators

ResMed GmbH & Co KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

March 12, 2020

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (ACTUAL)

June 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZNRW-KA_010_TB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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