Intubation, EndotrachealNCT00378651
Use of the Stethoscope to Confirm Breathing Tube Placement
A study testing Neck Auscultation in people with Intubation, Endotracheal, run by University of Manitoba at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation, Endotracheal
- What is being tested?
- Neck Auscultation
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Jan 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective surgery requiring general anesthesia with endotracheal intubation
Who cannot join
- Anticipated difficult intubation
- Contraindication to esophageal intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intubation, Endotracheal
- Being tested
- Neck Auscultation
- Keywords
- Intubation, Endotracheal, Anesthesia, General
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck AuscultationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Group accuracy: Correct identification of tube placement based on series of 30 sound files
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study startSep 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, EndotrachealStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Wei-Shuen Tan, BSc(Hon), MD, Principal investigator, Department of Anesthesia, University of ManitobaChris Christodoulou, MBCHB, FRCPC, Principal investigator, St. Boniface Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378651
- Sponsor's protocol ID
- CETINA-2
- Status last verified
- Dec 2007
- First submitted
- 19 Sep 2006
- Last updated
- 19 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiation Between Esophageal and Tracheal Intubation Utilizing Neck Auscultation
- ClinicalTrials.gov ID
- NCT00378651
- Acronym / sponsor ID
- CETINA-2
- Conditions
- Intubation, Endotracheal
- Keywords
- Intubation, Endotracheal, Anesthesia, General
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 20 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective surgery requiring general anesthesia with endotracheal intubation
Key exclusion criteria (2 listed)
- Anticipated difficult intubation
- Contraindication to esophageal intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck Auscultation | Procedure or surgery | – |
Primary outcome
Group accuracy: Correct identification of tube placement based on series of 30 sound files
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Shuen Tan, BSc(Hon), MD principal investigator
Department of Anesthesia, University of Manitoba
Chris Christodoulou, MBCHB, FRCPC principal investigator
St. Boniface Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck Auscultation in people with Intubation, Endotracheal, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group accuracy: Correct identification of tube placement based on series of 30 sound files. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2007.