Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Not Invasive Monitoring of Pleural Drainage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by RWTH Aachen University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
RWTH Aachen University Identifier:
First received: January 25, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

This Study ties to find out if data about monitoring the drainage after a pleural drainage can be collected by sensors.

Condition Intervention
Pleural Drainage
Device: Sensor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • data about sensors [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: October 2011
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pleural drainage Device: Sensor


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with pleural drainage


Inclusion Criteria:

  • patients with pleural effusion getting a pleural drainage
  • male and female patients aged at least 18 years

contorl group:

  • healthy male and female patients aged at least 18 years

Exclusion Criteria:

  • pregnancy or breast feeding
  • implanted pacemaker / CRT / ICD exept Medtronic 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 identifier: NCT01778270

Univeristy Hospital Aachen Recruiting
Aachen, North Rhine Westfalia, Germany, 52074
Contact: Patrick Schauerte, Prof. Dr. med.    +49 241 80 89669   
Principal Investigator: Patrick Schauerte, Prof. Dr. med.         
Sponsors and Collaborators
RWTH Aachen University
  More Information

No publications provided

Responsible Party: RWTH Aachen University Identifier: NCT01778270     History of Changes
Other Study ID Numbers: 10-078
Study First Received: January 25, 2013
Last Updated: January 25, 2013
Health Authority: Germany: Federal Institue for Drugs and Medicinal Devices processed this record on March 01, 2015