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

February 15, 2011 updated by: RWTH Aachen University

Bronchoscopy and Electric Impedance Tomography to Investigate the Influence of Bronchoscopy on Pulmonary Regional Ventilation Measurements by Electric Impedance Tomography (EIT)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • Recruiting
        • Faculty Medical Clinic 1, University Hospital Aachen
        • Contact:
          • Stefan Krueger, MD, Assistant Professor
          • Phone Number: 80202 ++49 241 80 80202
          • Email: stkrueger@ukaachen.de
        • Contact:
        • Principal Investigator:
          • Stefan Krueger, MD, Assist. Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Single Measurement of 1.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 14, 2011

Study Record Updates

Last Update Posted (Estimate)

February 16, 2011

Last Update Submitted That Met QC Criteria

February 15, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Bronchoscopy- EIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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