Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue SizeNCT02952560
A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size
An observational study of Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Difficulty in managing the airway is the single most important cause of major anesthesia-related morbidity and mortality. The currently used clinical method of predicting airway difficulty used by anesthetists is limited and not very highly sensitive or specific. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size
- What is being tested?
- Ultrasound scan
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Jun 2017
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for high resolution computerized tomography (CT scan) of the head and neck as part of their medical investigation of thyroid or laryngeal disorders will be recruited for this study.
Who may be able to join
- Age between 18 to 80 Years
- Gender: Both males and females are eligible for the study
- ASA I-III
- Scheduled for CT-scan of the head and neck as part of medical investigation (for test validation part)
Who cannot join
- Volunteer/ patient refusal
- Language Barrier
- Known oropharyngeal, laryngeal or head and neck disease or cancers
- Multiple amalgam fillings of the teeth
- Past history of oral or head and neck surgical procedures
- Past history of burns or radiotherapy of the head and neck region
- Presence of any scars, sinuses, infection, swelling, cysts in the head and neck region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size: Validation of Sonographic Technique
Difficulty in managing the airway is the single most important cause of major anesthesia-related morbidity and mortality. The currently used clinical method of predicting airway difficulty used by anesthetists is limited and not very highly sensitive or specific. Any additional bedside method that increases its specificity and sensitivity would be valuable. This project is designed to study and measure the tongue thickness and oral cavity height by using an ultrasound scan and comparing them with the same measurements obtained by CT scan. These will also be compared to a more complicated measurements used in previous studies to investigate any correlation with the currently used clinical methods. This information will help us decide if ultrasound may help Anesthesiologists assess difficulties in airway management in a more accurate, precise and reliable simpler method.
- Being tested
- Ultrasound scan
- Keywords
- Ultrasound, Computed Tomography, Oral cavity size, The Mallampati classification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanOther
Ultrasound scanning examinations will be performed twice (pre-CT scan and post CT-scan). Each examination will be performed by two observers who are blinded to each other's measured values.Patients will be asked to place a small sip of water (20 mL)in their mouth and keep the mouth open during the imaging. A second ultrasound examination of each patient by the two observers will be performed after the CT-scan.
| Study group | Role | What they receive |
|---|---|---|
| High resolution CT Scan of the head and neck | Patients scheduled for high resolution computerized tomography (CT scan) of the head and neck as part of their medical investigation of thyroid or laryngeal disorders will be recruited for this study. Receives: Other: Ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the assumption that ratio of "tongue thickness/oral cavity height" is a good estimate of the ratio "tongue volume/oral cavity volume" as measured by CT scan.
Measured: 2012-2013
Validity of ultrasound measurement of the two airway parameters (tongue thickness and height of oral cavity) against CT measurements of the same parameters.
Measured: 2012-2013
Secondary outcomes (2)
Reproducibility of the ultrasound measurements
Measured: 2012-2013
Correlating ultrasound measured values with Mallampati scores
Measured: 2012-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startMar 2012
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue SizeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent W.S Chan, MD, FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952560
- Sponsor's protocol ID
- 11-0791-AE
- Status last verified
- Oct 2016
- First submitted
- 31 Oct 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
Publications
Savva D. Prediction of difficult tracheal intubation. Br J Anaesth. 1994 Aug;73(2):149-53. doi: 10.1093/bja/73.2.149.
PubMed 7917726Werner SL, Smith CE, Goldstein JR, Jones RA, Cydulka RK. Pilot study to evaluate the accuracy of ultrasonography in confirming endotracheal tube placement. Ann Emerg Med. 2007 Jan;49(1):75-80. doi: 10.1016/j.annemergmed.2006.07.004. Epub 2006 Oct 2.
PubMed 17014927Lakhal K, Delplace X, Cottier JP, Tranquart F, Sauvagnac X, Mercier C, Fusciardi J, Laffon M. The feasibility of ultrasound to assess subglottic diameter. Anesth Analg. 2007 Mar;104(3):611-4. doi: 10.1213/01.ane.0000260136.53694.fe.
PubMed 17312218Tsui BC, Hui CM. Sublingual airway ultrasound imaging. Can J Anaesth. 2008 Nov;55(11):790-1. doi: 10.1007/BF03016357. No abstract available.
PubMed 19138924
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size: Validation of Sonographic Technique
- ClinicalTrials.gov ID
- NCT02952560
- Acronym / sponsor ID
- 11-0791-AE
- Keywords
- Ultrasound, Computed Tomography, Oral cavity size, The Mallampati classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Nov 2016 (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.
Difficulty in managing the airway is the single most important cause of major anesthesia-related morbidity and mortality. The currently used clinical method of predicting airway difficulty used by anesthetists is limited and not very highly sensitive or specific. Any additional bedside method that increases its specificity and sensitivity would be valuable. This project is designed to study and measure the tongue thickness and oral cavity height by using an ultrasound scan and comparing them with the same measurements obtained by CT scan. These will also be compared to a more complicated measurements used in previous studies to investigate any correlation with the currently used clinical methods. This information will help us decide if ultrasound may help Anesthesiologists assess difficulties in airway management in a more accurate, precise and reliable simpler method.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High resolution CT Scan of the head and neck | – | Other: Ultrasound scanPatients scheduled for high resolution computerized tomography (CT scan) of the head and neck as part of their medical investigation of thyroid or laryngeal disorders will be recruited for this study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for high resolution computerized tomography (CT scan) of the head and neck as part of their medical investigation of thyroid or laryngeal disorders will be recruited for this study.
Key inclusion criteria (4 listed)
- Age between 18 to 80 Years
- Gender: Both males and females are eligible for the study
- ASA I-III
- Scheduled for CT-scan of the head and neck as part of medical investigation (for test validation part)
Key exclusion criteria (7 listed)
- Volunteer/ patient refusal
- Language Barrier
- Known oropharyngeal, laryngeal or head and neck disease or cancers
- Multiple amalgam fillings of the teeth
- Past history of oral or head and neck surgical procedures
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 |
|---|---|---|
| Ultrasound scanUltrasound scanning examinations will be performed twice (pre-CT scan and post CT-scan). Each examination will be performed by two observers who are blinded to each other's measured values.Patients will be asked to place a small sip of water (20 mL)in their mouth and keep the mouth open during the imaging. A second ultrasound examination of each patient by the two observers will be performed after the CT-scan. | Other | High resolution CT Scan of the head and neck |
Primary outcome
Validity of the assumption that ratio of "tongue thickness/oral cavity height" is a good estimate of the ratio "tongue volume/oral cavity volume" as measured by CT scan.
Time frame: 2012-2013
Validity of ultrasound measurement of the two airway parameters (tongue thickness and height of oral cavity) against CT measurements of the same parameters.
Time frame: 2012-2013
2 secondary outcomes
Reproducibility of the ultrasound measurements
Time frame: 2012-2013
Correlating ultrasound measured values with Mallampati scores
Time frame: 2012-2013
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 6 Dec 2017.
- Background: PubMed 7917726Savva D. Prediction of difficult tracheal intubation. Br J Anaesth. 1994 Aug;73(2):149-53. doi: 10.1093/bja/73.2.149.
- Background: PubMed 17014927Werner SL, Smith CE, Goldstein JR, Jones RA, Cydulka RK. Pilot study to evaluate the accuracy of ultrasonography in confirming endotracheal tube placement. Ann Emerg Med. 2007 Jan;49(1):75-80. doi: 10.1016/j.annemergmed.2006.07.004. Epub 2006 Oct 2.
- Background: PubMed 17312218Lakhal K, Delplace X, Cottier JP, Tranquart F, Sauvagnac X, Mercier C, Fusciardi J, Laffon M. The feasibility of ultrasound to assess subglottic diameter. Anesth Analg. 2007 Mar;104(3):611-4. doi: 10.1213/01.ane.0000260136.53694.fe.
- Background: PubMed 19138924Tsui BC, Hui CM. Sublingual airway ultrasound imaging. Can J Anaesth. 2008 Nov;55(11):790-1. doi: 10.1007/BF03016357. No abstract available.
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.
Vincent W.S Chan, MD, FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size, run by University Health Network, Toronto 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 4 inclusion and 7 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 6 Dec 2017. 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?
Validity of the assumption that ratio of "tongue thickness/oral cavity height" is a good estimate of the ratio "tongue volume/oral cavity volume" as measured by CT scan. (time frame: 2012-2013). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02952560, which also lists 4 linked publications.
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 6 Dec 2017.