Use of the Stethoscope to Confirm Breathing Tube Placement

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00378651
First received: September 19, 2006
Last updated: December 14, 2007
Last verified: December 2007
  Purpose

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 Intervention
Intubation, Endotracheal
Procedure: Neck Auscultation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Differentiation Between Esophageal and Tracheal Intubation Utilizing Neck Auscultation

Further study details as provided by University of Manitoba:

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

Estimated Enrollment: 23
Study Start Date: September 2006
Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective surgery requiring general anesthesia with endotracheal intubation

Exclusion Criteria:

  • Anticipated difficult intubation
  • Contraindication to esophageal intubation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378651

Locations
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00378651     History of Changes
Other Study ID Numbers: CETINA-2
Study First Received: September 19, 2006
Last Updated: December 14, 2007
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on October 20, 2014