Not Invasive Monitoring of Pleural Drainage

RWTH Aachen University50 enrolled

Overview

This study investigates if data about monitoring the drainage of pleural effusion can be collected by non invasive sensors (feasibility).

25 patients \> 18 years old with pleura effusion will be examined with regard to the feasibility of non invasive sensor measurements corresponding to the course of thorax impedance and respiration parameters during body fluids loss before and after pleural drainage. The measured data will be compared to standard routine reference measurements (heart rate, medication, brain natriuretic peptide (BNP), heart minute volume). Additionally heart sound analysis via electronic stethoscope will be compared to standard methods. Also 25 healthy controls will undergo the same measurements to receive standard values.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pleural Effusion

Interventions

Body Bioimpedance SensorDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * patients with pleural effusion undergoing pleural drainage * male and female patients aged at least 18 years Exclusion Criteria: * pregnancy or breast feeding * implanted pacemaker / Cardiac Resynchronization Therapy (CRT) / Implanted Cardioverter Defibrillator (ICD) except Medtronic Device "OptiVol". * patients not being able to consent

Locations (1)

Univeristy Hospital Aachen

Aachen, North Rhine Westfalia, Germany

Outcomes

Primary Outcomes

Change of thorax impedance (Ohm)

non invasive bioimpedance measurements to determine feasibility of body fluid loss before and after pleura drainage in 25 patients \> 18 years old; also 25 healthy controls are measured to receive standard values

Time frame: once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour.

Secondary Outcomes

Change of Cardiac output ( l/min) via impedance cardiography

non invasive bioimpedance measurements to determine feasibility of impedance cardiography before and after pleura drainage; also 25 healthy controls are measured to receive standard values

Time frame: once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour

Data from ClinicalTrials.gov

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