Electrical Impedance Tomography for Endotracheal Tube Placement
| Tracking Information | |||||
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| First Received Date ICMJE | January 25, 2010 | ||||
| Last Updated Date | November 9, 2010 | ||||
| Start Date ICMJE | September 2008 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01237756 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Electrical Impedance Tomography for Endotracheal Tube Placement | ||||
| Official Title ICMJE | Electrical Impedance Tomography for Endotracheal Tube Placement in Pediatric Patients | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | |||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Caregiver) Primary Purpose: Diagnostic |
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| Condition ICMJE | Endotracheal Tube Placement | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: pediatric
Intervention: Device: measurement of left and right lung ventilation |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 18 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 10 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01237756 | ||||
| Other Study ID Numbers ICMJE | 198/08 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. med. Daniel Steinmann, University Medical Center Freiburg | ||||
| Study Sponsor ICMJE | University Hospital Freiburg | ||||
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| Investigators ICMJE |
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| Information Provided By | University Hospital Freiburg | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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