Not Invasive Monitoring of Pleural Drainage

NCT01778270 | Completed

• 1 other identifier: 10-078
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pleural Effusion

Keywords

pleural effusion; pleural drainage; thorax impedance; respiration parameters; heart sounds analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Change of respiratory parameter CO2 in %/ml exhaled air

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

Study Arms (2)

non invasive sensor pleural drainage

OTHER

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

non invasive sensor healthy control

OTHER

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

Interventions

Body Bioimpedance Sensor DEVICE

non invasive sensor healthy control; non invasive sensor pleural drainage

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with pleural effusion undergoing pleural drainage
• male and female patients aged at least 18 years

You may not qualify if:

• pregnancy or breast feeding
• implanted pacemaker / Cardiac Resynchronization Therapy (CRT) / Implanted Cardioverter Defibrillator (ICD) except Medtronic Device "OptiVol".
• patients not being able to consent

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Univeristy Hospital Aachen

Aachen, North Rhine Westfalia, 52074, Germany

Location

Related Publications (1)

• 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.

  PMID: 25861647 DERIVED

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Nikolaus Marx, MD

  Medical Clinic I, University Hospital Aachen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: October 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

DE (1)