Use of the Stethoscope to Confirm Breathing Tube Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378651
Recruitment Status : Completed
First Posted : September 20, 2006
Last Update Posted : December 19, 2007
Information provided by:
University of Manitoba

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Intubation, Endotracheal Procedure: Neck Auscultation Not Applicable

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 : Interventional  (Clinical Trial)
Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Differentiation Between Esophageal and Tracheal Intubation Utilizing Neck Auscultation
Study Start Date : September 2006
Actual Study Completion Date : January 2007

Primary Outcome Measures :
  1. Group accuracy: Correct identification of tube placement based on series of 30 sound files

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Elective surgery requiring general anesthesia with endotracheal intubation

Exclusion Criteria:

  • Anticipated difficult intubation
  • Contraindication to esophageal intubation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378651

Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
Principal Investigator: Wei-Shuen Tan, BSc(Hon), MD Department of Anesthesia, University of Manitoba
Principal Investigator: Chris Christodoulou, MBCHB, FRCPC St. Boniface General Hospital Research Centre Identifier: NCT00378651     History of Changes
Other Study ID Numbers: CETINA-2
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: December 19, 2007
Last Verified: December 2007

Keywords provided by University of Manitoba:
Intubation, Endotracheal
Anesthesia, General