Clincosm LogoSign in Get a demo

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

Sponsor
RWTH Aachen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01294813
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
3
Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Electrical Impedance Tomography (EIT)
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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)
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Apr 1, 2011
Anticipated Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Comparison of the change in lung impedance due to ventilation before and after bronchoscopy by EIT measurements [Single Measurement of 1.5 hours]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Faculty Medical Clinic 1, University Hospital Aachen Aachen Nordrhein-Westfalen Germany 52074

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01294813
Other Study ID Numbers:
  • Bronchoscopy- EIT
First Posted:
Feb 14, 2011
Last Update Posted:
Feb 16, 2011
Last Verified:
Feb 1, 2011
Keywords provided by , ,
Electric Impedance Tomography (EIT)
Ventilation
Bronchoscopy
Lung Impedance
Recruitment

Study Results

No Results Posted as of Feb 16, 2011