Bronchoscopy and Electric Impedance Tomography (EIT) Pilot Study

NCT01294813 | Unknown

• 1 other identifier: Bronchoscopy- EIT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Electric Impedance Tomography; Bronchoscopy; Change in Lung Impedance Due to Ventilation; Recruitment; Improvement the Treatment of the Patient

Keywords

Electric Impedance Tomography (EIT); Ventilation; Bronchoscopy; Lung Impedance; Recruitment

Outcome Measures

Primary Outcomes (1)

• Comparison of the change in lung impedance due to ventilation before and after bronchoscopy by EIT measurements

  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

Study Arms (1)

Bronchoscopy-EIT

EXPERIMENTAL

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)

Interventions

Electrical Impedance Tomography (EIT) DEVICE

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.

Bronchoscopy-EIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Faculty Medical Clinic 1, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Krueger, MD, Assoc. Prof.

  University Hospital Aachen, Medical Clinic 1, Section of Pneumology, 52074 Aachen, Nordrhein-Westfalen, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Krueger, MD

CONTACT

0049 241 8080202; stkrueger@ukaachen.de

Sigrid Gloeggler, M.Sc.

CONTACT

0049 241 8035226; sgloeggler@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 14, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 16, 2011

Record last verified: 2011-02

Locations

DE (1)