Not Invasive Monitoring of Pleural Drainage

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

Study Overview

• Status: Completed
• Conditions: Pleural Effusion
• Intervention / Treatment: Device: Body Bioimpedance Sensor

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine Westfalia
    • Aachen, North Rhine Westfalia, Germany, 52074
      • Univeristy Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: non invasive sensor pleural drainage; 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
Other: non invasive sensor healthy control; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of respiratory parameter CO2 in %/ml exhaled air	respiratory parameters as CO2 in %/ml exhaled volume will be determined via capnograph	once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Study Director: Nikolaus Marx, MD, Medical Clinic I, University Hospital Aachen

Publications and helpful links

General Publications

• Zink MD, Weyer S, Pauly K, Napp A, Dreher M, Leonhardt S, Marx N, Schauerte P, Mischke K. Feasibility of bioelectrical impedance spectroscopy measurement before and after thoracentesis. Biomed Res Int. 2015;2015:810797. doi: 10.1155/2015/810797. Epub 2015 Mar 11.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: January 25, 2013
• First Posted (Estimate): January 29, 2013

Study Record Updates

• Last Update Posted (Estimate): April 16, 2015
• Last Update Submitted That Met QC Criteria: April 15, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: pleural effusion; pleural drainage; thorax impedance; respiration parameters; heart sounds analysis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: 10-078