Not Invasive Monitoring of Pleural Drainage

NCT ID: NCT01778270

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-04-30

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.

Conditions

Pleural Effusion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Body Bioimpedance Sensor

Intervention Type: DEVICE

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.

Group Type: OTHER

Body Bioimpedance Sensor

Intervention Type: DEVICE

Interventions

Body Bioimpedance Sensor

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikolaus Marx, MD

Role: STUDY_DIRECTOR

Medical Clinic I, University Hospital Aachen

Locations

Univeristy Hospital Aachen

Aachen, North Rhine Westfalia, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 25861647 (View on PubMed)

Other Identifiers

10-078

Identifier Type: -

Identifier Source: org_study_id