Not Invasive Monitoring of Pleural Drainage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01778270
First received: January 25, 2013
Last updated: April 15, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention
Pleural Effusion
Device: Body Bioimpedance Sensor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Not Invasive Monitoring of Pleural Drainage

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    respiratory parameters as CO2 in %/ml exhaled volume will be determined via capnograph


Enrollment: 50
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778270

Locations
Germany
Univeristy Hospital Aachen
Aachen, North Rhine Westfalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Director: Nikolaus Marx, MD Medical Clinic I, University Hospital Aachen
  More Information

No publications provided by RWTH Aachen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01778270     History of Changes
Other Study ID Numbers: 10-078
Study First Received: January 25, 2013
Last Updated: April 15, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
pleural effusion
pleural drainage
thorax impedance
respiration parameters
heart sounds analysis

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 30, 2015