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Not Invasive Monitoring of Pleural Drainage

Not Invasive Monitoring of Pleural Drainage

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01778270
Enrollment
50
Registered
2013-01-29
Start date
2011-10-31
Completion date
2013-04-30
Last updated
2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Effusion

Keywords

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

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.

Interventions

DEVICEBody Bioimpedance Sensor

Sponsors

RWTH Aachen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of thorax impedance (Ohm)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

MeasureTime frameDescription
Change of Cardiac output ( l/min) via impedance cardiographyonce during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hournon 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

MeasureTime frameDescription
Change of respiratory parameter CO2 in %/ml exhaled aironce during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hourrespiratory parameters as CO2 in %/ml exhaled volume will be determined via capnograph

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026