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Completed

NCT Number: NCT01778270

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).

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Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy Hospital Aachen

Aachen, North Rhine Westfalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body Bioimpedance Sensor

Device

Primary outcomes

  1. Change of thorax impedance (Ohm)

    Time frame: 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 outcomes

  1. Change of Cardiac output ( l/min) via impedance cardiography

    Time frame: 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

Other outcomes

  1. Change of respiratory parameter CO2 in %/ml exhaled air

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

    respiratory parameters as CO2 in %/ml exhaled volume will be determined via capnograph

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 29, 2013
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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