Bronchoscopy and Electric Impedance Tomography (EIT) Pilot Study

NCT ID: NCT01294813

Last Updated: 2011-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-04-30

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Electrical Impedance Tomography (EIT)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. med. Stefan Krueger, Medical Clinic 1, RWTH Aachen University Hospital, Section of Cardiology, Pneumology and Angiology

Principal Investigators

Stefan Krueger, MD, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Faculty Medical Clinic 1, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Stefan Krueger, MD

Role: CONTACT

stkrueger@ukaachen.de

0049 241 8080202 ext. 80202

Sigrid Gloeggler, M.Sc.

Role: CONTACT

sgloeggler@ukaachen.de

0049 241 8035226 ext. 35226

Facility Contacts

Stefan Krueger, MD, Assistant Professor

Role: primary

stkrueger@ukaachen.de

++49 241 80 80202 ext. 80202

Sigrid Gloeggler, M.Sc.

Role: backup

sgloeggler@ukaachen.de

++49 241 8035226 ext. 35226

Other Identifiers

Bronchoscopy- EIT

Identifier Type: -

Identifier Source: org_study_id