Not Invasive Monitoring of Pleural Drainage

Not Applicable

Completed

• Conditions: Pleural Effusion
• Interventions: Device: Body Bioimpedance Sensor

• Registration Number: NCT01778270
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-29
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non invasive sensor pleural drainage	Body Bioimpedance Sensor	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.
non invasive sensor healthy control	Body Bioimpedance Sensor	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.

Primary Outcome Measures

Name	Time	Method
Change of thorax impedance (Ohm)	once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour.	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

Secondary Outcome Measures

Name	Time	Method
Change of Cardiac output ( l/min) via impedance cardiography	once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour	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

Trial Locations

Locations (1)

Univeristy Hospital Aachen; 🇩🇪 Aachen, North Rhine Westfalia, Germany