Bronchoscopy and Electric Impedance Tomography (EIT) Pilot Study (Broncho-EIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by RWTH Aachen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01294813
First received: February 10, 2011
Last updated: February 15, 2011
Last verified: February 2011
  Purpose

Electrical Impedance Tomography (EIT)is a technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a radiation free, non-invasive and portable lung imaging technique. Impedance changes in lung ventilation are investigated in mechanically ventilated patients who routinely undergo bronchoscopy in intensive care medicine. Bronchoscopy is performed to suction secretions as well as to analyze the secretions to recognize inflammations and diseases. It is an essential intervention which causes changes in ventilation which remain for 1-2 hours. It is not completely investigated why these changes in ventilation remain for so long time and how they are distributed regionally. Therefore the purpose of this study is to investigate the change in pulmonary regional ventilation in patients who routinely undergo bronchoscopy to possibly generate ideas how to optimize the ventilation after bronchoscopy to optimize the patient´s treatment.


Condition Intervention
Electric Impedance Tomography
Bronchoscopy
Change in Lung Impedance Due to Ventilation
Recruitment
Improvement the Treatment of the Patient
Device: Electrical Impedance Tomography (EIT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bronchoscopy and Electric Impedance Tomography to Investigate the Influence of Bronchoscopy on Pulmonary Regional Ventilation Measurements by Electric Impedance Tomography (EIT)

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Comparison of the change in lung impedance due to ventilation before and after bronchoscopy by EIT measurements [ Time Frame: Single Measurement of 1.5 hours ] [ Designated as safety issue: No ]
    It will be investigated if there are changes in lung impedance due to changes in ventilation before, directly after and 10, 30, 60 minutes after bronchoscopy in order to investigate their regional distribution and to generate ideas how the ventilation could be optimized to improve recruitment of the patient´s treatment


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bronchoscopy-EIT
Patients who routinely undergo bronchoscopy will be measured by EIT directly before, directly after and 10, 30, 60 minutes after bronchoscopy with a rubber belt which is placed around their chest. The EIT measurements will take 1-2 minutes; the total examination will last 1.5 hours.
Device: Electrical Impedance Tomography (EIT)
EIT measurements of 1-2 minutes are performed in patients who routinely undergo bronchoscopy (during 1.5 hours) before, directly after and 10, 30, 60 minutes after bronchoscopy. Therefore the rubber belt including 16 integrated electrographic electrodes is placed around the patient´s chest and connected with an EIT device. EIT data are generated by application of a small alternating current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. Pseudonomyzed EIT data are evaluated descriptively.

Detailed Description:

In 20 mechanically ventilated patients who routinely undergo bronchoscopy Electrical Impedance Tomography (EIT) measurements whereby, evaluable data of 10 patients are needed, of about 1-2 minutes are performed directly before, directly after and 10, 30, and 60 minutes after bronchoscopy parallel to the following routine measurements: tidal volume, resistance, compliance, heart rate, blood pressure, SpO2 and blood gas values. Prior to the examination a rubber belt with 16 integrated electrocardiographic electrodes is placed around the thorax connected with an EIT- device. EIT data are generated by application of a small alternating current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. The EIT provides a mapping of the distribution of the lung´s electrical impedance and exhibits a far temporal resolution of up to 40 tomograms per second. Because of electrical impedance of the pulmonal tissue is dependant to the air content, the air distribution within the lung over a certain period can be monitored. Analyzing the EIT- data it might be possible to explain the distribution in regional ventilation and how the ventilation could be optimized right after the bronchoscopy to optimize the patient´s treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male patients > 18 years old
  • Mechanically ventilated patients who routinely undergo bronchoscopy

Exclusion Criteria:

  • Pregnancy and Breastfeeding
  • Active implants, heart pace makers and implanted converter defibrillator
  • Foreign metallic objects in the thorax
  • Cardiac valves
  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: NCT01294813

Contacts
Contact: Stefan Krueger, MD 0049 241 8080202 ext 80202 stkrueger@ukaachen.de
Contact: Sigrid Gloeggler, M.Sc. 0049 241 8035226 ext 35226 sgloeggler@ukaachen.de

Locations
Germany
Faculty Medical Clinic 1, University Hospital Aachen Recruiting
Aachen, Nordrhein-Westfalen, Germany, 52074
Contact: Stefan Krueger, MD, Assistant Professor    ++49 241 80 80202 ext 80202    stkrueger@ukaachen.de   
Contact: Sigrid Gloeggler, M.Sc.    ++49 241 8035226 ext 35226    sgloeggler@ukaachen.de   
Principal Investigator: Stefan Krueger, MD, Assist. Prof.         
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Stefan Krueger, MD, Assoc. Prof. University Hospital Aachen, Medical Clinic 1, Section of Pneumology, 52074 Aachen, Nordrhein-Westfalen, Germany
  More Information

No publications provided

Responsible Party: Stefan Krueger, MD, Assistant Professor, PD Dr. med. Stefan Krueger, Medical Clinic 1, RWTH Aachen University Hospital, Section of Cardiology, Pneumology and Angiology
ClinicalTrials.gov Identifier: NCT01294813     History of Changes
Other Study ID Numbers: Bronchoscopy- EIT
Study First Received: February 10, 2011
Last Updated: February 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
Electric Impedance Tomography (EIT)
Ventilation
Bronchoscopy
Lung Impedance
Recruitment

ClinicalTrials.gov processed this record on August 18, 2014