Electrical Impedance Tomography for Endotracheal Tube Placement

November 9, 2010 updated by: University Hospital Freiburg

Electrical Impedance Tomography for Endotracheal Tube Placement in Pediatric Patients

Endobronchial tube misplacement is serious complication during general anesthesia in pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is crucial. Several methods have been suggested for determination of correct ETT placement. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several methods have been suggested for determination of correct ETT placement. These include for example the marker method, the mainstem method or the formula method. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes. For this purpose, pediatric patients are routinely intubated for cardiac catheterization using the mainstem method or 3xETT size method. Placement of the ETT is then verified by intraoperative fluoroscopy and lung ventilation is verified by EIT.

Study Type

Interventional

Enrollment (Actual)

18

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 Locations

  • Germany
      • Freiburg, Germany, 79106
        • University Medical Center Freiburg

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

1 week to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent from the parents
  • endotracheal intubation with a standard endotracheal tube

Exclusion Criteria:

  • refusal of written informed consent
  • severe lung diseases
  • contraindication for use of electrical impedance tomography

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pediatric
Device: measurement of left and right lung ventilation
Patients are ventilated after endotracheal tube placement and left and right lung ventilation if determined using electrical impedance tomography
Other Names:
  • EIT, Draeger

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
determination of proper endotracheal tube placement
Time Frame: endotracheal tube placement is immediately verified after endotracheal intubation with fluoroscopy and electrical impedance tomography during the general anesthesia for cardiac catheterization
endotracheal tube placement is immediately verified after endotracheal intubation with fluoroscopy and electrical impedance tomography during the general anesthesia for cardiac catheterization

Collaborators and Investigators

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

Sponsor

University Hospital Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 198/08

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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