Use of the Stethoscope to Confirm Breathing Tube Placement

Intubation, Endotracheal Clinical Trial

Official title:

Differentiation Between Esophageal and Tracheal Intubation Utilizing Neck Auscultation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378651
• Other study ID #: CETINA-2
• Status: Completed
• Phase: N/A
• First received: September 19, 2006
• Last updated: December 14, 2007
• Start date: September 2006
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective surgery requiring general anesthesia with endotracheal intubation

Exclusion Criteria:

• Anticipated difficult intubation

• Contraindication to esophageal intubation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intubation, Endotracheal

Intervention

Procedure:
• Neck Auscultation

Locations

Country	Name	City	State
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Group accuracy: Correct identification of tube placement based on series of 30 sound files