Electrical Impedance Tomography for Endotracheal Tube Placement

This study has been completed.
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT01237756
First received: January 25, 2010
Last updated: November 9, 2010
Last verified: June 2008
  Purpose

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.


Condition Intervention
Endotracheal Tube Placement
Device: measurement of left and right lung ventilation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
Official Title: Electrical Impedance Tomography for Endotracheal Tube Placement in Pediatric Patients

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: EIT, Draeger

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.

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237756

Locations
Germany
University Medical Center Freiburg
Freiburg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Daniel Steinmann, MD University Medical Center Freiburg
  More Information

Publications:
Responsible Party: Dr. med. Daniel Steinmann, University Medical Center Freiburg
ClinicalTrials.gov Identifier: NCT01237756     History of Changes
Other Study ID Numbers: 198/08
Study First Received: January 25, 2010
Last Updated: November 9, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
pediatric anesthesia
endotracheal tube
electrical impedance tomography
misplacement
endobronchial

ClinicalTrials.gov processed this record on April 17, 2014