Not Invasive Monitoring of Pleural Drainage

Pleural Effusion Clinical Trial

Official title:

Not Invasive Monitoring of Pleural Drainage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778270
• Other study ID #: 10-078
• Status: Completed
• Phase: N/A
• First received: January 25, 2013
• Last updated: April 15, 2015
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Device:
• Body Bioimpedance Sensor

Locations

Country	Name	City	State
Germany	Univeristy Hospital Aachen	Aachen	North Rhine Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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.	No
Secondary	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	No