Not Invasive Monitoring of Pleural Drainage

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

Detailed Description
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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.

Official Title
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Not Invasive Monitoring of Pleural Drainage

Conditions
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Pleural Effusion

Intervention / Treatment
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* Device: Body Bioimpedance Sensor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: non invasive sensor pleural drainage<br>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. | Device: Body Bioimpedance Sensor<br> <br> |
| Other: non invasive sensor healthy control<br>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. | Device: Body Bioimpedance Sensor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pleural effusion, pleural drainage, thorax impedance, respiration parameters, heart sounds analysis