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

January 25, 2010
November 9, 2010
September 2008
May 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01237756 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Electrical Impedance Tomography for Endotracheal Tube Placement
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
Endotracheal Tube Placement
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
Experimental: pediatric
Intervention: Device: measurement of left and right lung ventilation
Steinmann D, Stahl CA, Minner J, Schumann S, Loop T, Kirschbaum A, Priebe HJ, Guttmann J. Electrical impedance tomography to confirm correct placement of double-lumen tube: a feasibility study. Br J Anaesth. 2008 Sep;101(3):411-8. Epub 2008 Jun 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2010
May 2009   (final data collection date for primary outcome measure)

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
Both
up to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01237756
198/08
No
Dr. med. Daniel Steinmann, University Medical Center Freiburg
University Hospital Freiburg
Not Provided
Principal Investigator: Daniel Steinmann, MD University Medical Center Freiburg
University Hospital Freiburg
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP