- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378651
Use of the Stethoscope to Confirm Breathing Tube Placement
Differentiation Between Esophageal and Tracheal Intubation Utilizing Neck Auscultation
This study is intended to validate the use of neck auscultation with an electronic stethoscope during intubation to confirm tracheal tube placement.
It is hypothesized that the ability to confirm correct tube placement with this technique will be similar to that of the end-tidal CO2 monitor, the current gold-standard device for confirming tracheal intubation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Unrecognized esophageal intubation results in disastrous consequences. Fortunately, a variety of techniques have been cited to confirm placement of the endotracheal tube. However, even end-tidal CO2 monitoring, considered to be the gold standard, has been associated with false positive and false negative results. In addition, use of this monitor requires ventilation through the tube, resulting in gastric distention if the esophagus has been intubated.
When the lateral neck is auscultated during insertion of an endotracheal tube, there is a distinct difference between the sounds generated by a tube placed in the esophagus compared to a tube inserted into the trachea. Stethoscopes are readily available in any OR setting, and ventilation and release of cricoid pressure need not occur prior to confirmation of tube placement. However, this technique has yet to be validated.
A series of sounds heard at the lateral neck during both tracheal and esophageal intubation will be recorded using an electronic stethoscope. These sound files will be played to a group including both experienced and inexperienced intubators, who will be asked to identify which sounds represent tracheal and esophageal intubation. Overall accuracy will be determined for the group of listeners.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- St. Boniface General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elective surgery requiring general anesthesia with endotracheal intubation
Exclusion Criteria:
- Anticipated difficult intubation
- Contraindication to esophageal intubation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Group accuracy: Correct identification of tube placement based on series of 30 sound files
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wei-Shuen Tan, BSc(Hon), MD, Department of Anesthesia, University of Manitoba
- Principal Investigator: Chris Christodoulou, MBCHB, FRCPC, St. Boniface Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CETINA-2
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