Not Invasive Monitoring of Pleural Drainage

RWTH Aachen University

Status: Completed

Conditions: Pleural Effusion

Treatments: Device: Body Bioimpedance Sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT01778270

10-078

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

non invasive sensor pleural drainage

Other group

Description:

feasibility data will be collected with thorax impedance measurements via body bioimpedance sensor in Ohm before and after pleura drainage, via impedance cardiography stroke volume and cardiac output will be calculated and also respiratory parameters determined via capnograph as carbon dioxide (CO2) in %/ml exhaled volume before and after pleura drainage. Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.

Treatment:

Device: Body Bioimpedance Sensor

non invasive sensor healthy control

Other group

Description:

the same measurements as in arm 1: feasibility data will be collected with thorax impedance measurements via body bioimpedance sensor before and after pleura drainage in Ohm, via impedance cardiography stroke volume and cardiac output will be calculated and also respiratory parameters determined via capnograph as carbon dioxide (CO2) in %/ml exhaled volume once in 25 healthy controls. Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.

Treatment:

Device: Body Bioimpedance Sensor