Airway ManagementNCT05466409
Upper Airway Ultrasound Training Requirements
An observational study of Airway Management, run by University of Ioannina at 1 site in Greece.
Trial summary
The applications of point-of-care ultrasonography (POCUS) of the upper airway are growing over the last decade. It's clinical applications include both diagnosis of upper airway pathology as well as pre-intubation airway examination and provision of ultrasound markers of difficult laryngoscopy and/or intubation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- Visualization of the hyoid bone, Visualization of vocal cords and Localization of thyrohyoid membrane
- How many people
- 22 participants
- Where
- 1 siteGreece
- Study dates
- 29 Nov 2021to 13 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers, all members of the Operating Room (OR) staff, not anticipated to have difficult laryngoscopy and/or intubation based on their clinical upper airway evaluation.
Who may be able to join
- healthy adult volunteers (ASA physical status I and II)
Who cannot join
- history of congenital or acquired airway abnormalities
- modified Simplified Airway Risk Index (SARI) > 4
- mallampati score > 3
- Body mass index (BMI) > 35 Kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training Requirements in Point of Care Ultrasonography of the Upper Airway. A Feasibility Study
The applications of point-of-care ultrasonography (POCUS) of the upper airway are growing over the last decade. It's clinical applications include both diagnosis of upper airway pathology as well as pre-intubation airway examination and provision of ultrasound markers of difficult laryngoscopy and/or intubation.
However, it is differentiated from the comprehensive ultrasound examinations traditionally performed by radiologists because it is targeted to answer a specific clinical question in real time. Moreover, ultrasound-guided techniques require knowledge of sonoanatomy and ultrasound operational skills. However, clinicians lack the standardized training that ultrasound technicians and radiologists receive. POCUS training is rarely done in a standardized manner, and even more so, POCUS is rarely conducted under expert's supervision.
The current study investigates the feasibility of upper airway POCUS performed on healthy volunteers by anaesthesia residents using a predefined scanning protocol after attending a structured training course. Assessment of anaesthesia trainees' competence and minimum training requirements were the aim of the study.
Read the detailed description
Point-of-care (POCUS) of the upper airway has proven a useful tool for airway management as well as diagnosis of upper airway pathology. Although anaesthesiologists are familiar with the use of ultrasound, with peripheral nerve blockade and vascular access representing the most popular applications in anaesthesiology, POCUS is not yet routinely used for airway evaluation. However, the reliability of such examination, which is clinician performed and interpreted, is highly dependent on the operator. Ultrasound-guided techniques require knowledge of sonoanatomy and ultrasound operational skills. Clinicians lack the standardized training that ultrasound technicians and radiologists receive. POCUS training is rarely done in a standardized manner, and even more so, POCUS is rarely conducted under expert's supervision. Insufficient ultrasonographic skills increase the risk of misdiagnosis compromising patient care.
This is a prospective observational study conducted in the University Hospital of Ioannina to investigate the feasibility of upper airway POCUS performed on healthy volunteers by anaesthesia residents using a predefined scanning protocol after attending a structured training course. Assessment of anaesthesia trainees' competence and minimum training requirements are the aim of the study.
All subjects will be healthy volunteer members of the Operating Room (OR) staff. The training course will be shaped in a stepwise manner, beginning with an "education day" that includes a didactic lecture and a hands-on workshop, followed by a "performance week" for competence assessment. During "education day" a predefined scanning protocol will be taught and practiced. An experienced in neck ultrasound radiologist (instructor) will demonstrate the scans and will supervise all trainees. The predefined scanning protocol includes identification of specific structures [(i) visualization of the hyoid bone, (ii) visualization of vocal cords, (iii) localization of thyrohyoid membrane and visualization of epiglottis and pre-epiglottic space, (iv) visualization of cricothyroid membrane, and (v) visualization of thyroid gland)], as well as performance of specific measurements [(i) distance from hyoid bone to skin, (ii) distance from anterior commissure to skin, (iii) distance from epiglottis to skin, and (iv) distance from thyroid isthmus to skin].
During "performance week" all trainees will perform upper airway POCUS to members of the OR staff. The predefined protocol will be applied in each case. A single scan will be allowed for each subject. All subjects will have ultrasound measurements recorded separately by the six trainees and the instructor. The data will be collected at bedside and each participant will be blinded to each other's assessments. Trainees' performance will be assessed by paired calculations of the trainee - instructor differences in all ultrasound measurements of interest.
- Conditions
- Airway Management
- Being tested
- Visualization of the hyoid bone, Visualization of vocal cords, Localization of thyrohyoid membrane, Visualization of epiglottis and pre-epiglottic space, Visualization of cricothyroid membrane
- Keywords
- Training, Point-of-care-ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualization of the hyoid boneOther
Visualization of the hyoid bone using POCUS of upper airway (probe positioning: transverse plane). Hyoid bone visualization will be assessed as a binary outcome (yes/no).
Visualization of vocal cordsOther
Visualization of the vocal cords through the cricoid cartilage using POCUS of upper airway (probe positioning: transverse plane). Vocal cords visualization will be assessed as a binary outcome (yes/no).
Localization of thyrohyoid membraneOther
Localization of thyrohyoid membrane using POCUS of upper airway (probe positioning: midsagittal plane). Thyrohyoid membrane visualization will be assessed as a binary outcome (yes/no).
Visualization of epiglottis and pre-epiglottic spaceOther
Visualization of epiglottis and pre-epiglottic space using POCUS of upper airway (probe positioning: midsagittal plane). Epiglottis and pre-epiglottic space visualization will be assessed as a binary outcome (yes/no).
Visualization of cricothyroid membraneOther
Visualization of cricothyroid membrane using POCUS of upper airway (probe positioning: midsagittal plane). Cricothyroid membrane visualization will be assessed as a binary outcome (yes/no).
Visualization of thyroid glandOther
Visualization of thyroid gland using POCUS of upper airway (probe positioning: transverse plane). Thyroid gland visualization will be assessed as a binary outcome (yes/no).
Hyoid bone to skin distanceOther
Measurement of hyoid bone to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane).
Anterior commissure to skin distanceOther
Measurement of anterior commissure to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane).
Epiglottis to skin distanceOther
Measurement of epiglottis to skin distance (mm) using POCUS of upper airway (probe positioning: midsagittal plane).
Thyroid isthmus to skin distanceOther
Measurement of thyroid isthmus to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane).
What is being measured
The primary outcome is the main question the study is designed to answer.
T-I differences for hyoid bone to skin distance
Paired calculations of trainee-instructor (T-I) differences (mm) for hyoid bone to skin distance.
Measured: 10 days
T-I differences for anterior commissure to skin distance
Paired calculations of trainee-instructor (T-I) differences (mm) for anterior commissure to skin distance.
Measured: 10 days
T-I differences for epiglottis to skin distance
Paired calculations of trainee-instructor (T-I) differences (mm) for epiglottis to skin distance.
Measured: 10 days
T-I differences for thyroid isthmus to skin distance
Paired calculations of trainee-instructor (T-I) differences (mm) for thyroid isthmus to skin distance.
Measured: 10 days
Secondary outcomes (6)
Hyoid bone visualization
Success rate (%) for hyoid bone visualization using upper airway POCUS (transverse plane).
Measured: 10 days
Vocal cords visualization
Success rate (%) for vocal cords visualization using upper airway POCUS (transverse plane).
Measured: 10 days
Thyrohyoid membrane localization, epiglottis and pre-epiglottic space visualization
Success rate (%) for thyrohyoid membrane localization, epiglottis and pre-epiglottic space visualization using upper airway POCUS. All structures (thyrohyoid membrane, epiglottis and pre-epiglottic space) will be assessed under one view with the probe positioned in the midsagittal plane.
using upper airway POCUS (transverse plane).
Measured: 10 days
Cricothyroid membrane visualization
Success rate (%) for cricothyroid membrane visualization using upper airway POCUS (midsagittal plane).
Measured: 10 days
Thyroid gland visualization
Success rate (%) for thyroid gland visualization using upper airway POCUS (transverse plane).
Measured: 10 days
Sanning duration
Total duration (seconds) of the predefined scanning protocol.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start29 Nov 2021
- Primary completion6 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agathi Karakosta, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466409
- Sponsor's protocol ID
- 942
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Requirements in Point of Care Ultrasonography of the Upper Airway. A Feasibility Study
- ClinicalTrials.gov ID
- NCT05466409
- Acronym / sponsor ID
- 942
- Conditions
- Airway Management
- Keywords
- Training, Point-of-care-ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 20 Jul 2022 (actual)
- 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.
The applications of point-of-care ultrasonography (POCUS) of the upper airway are growing over the last decade. It's clinical applications include both diagnosis of upper airway pathology as well as pre-intubation airway examination and provision of ultrasound markers of difficult laryngoscopy and/or intubation.
However, it is differentiated from the comprehensive ultrasound examinations traditionally performed by radiologists because it is targeted to answer a specific clinical question in real time. Moreover, ultrasound-guided techniques require knowledge of sonoanatomy and ultrasound operational skills. However, clinicians lack the standardized training that ultrasound technicians and radiologists receive. POCUS training is rarely done in a standardized manner, and even more so, POCUS is rarely conducted under expert's supervision.
The current study investigates the feasibility of upper airway POCUS performed on healthy volunteers by anaesthesia residents using a predefined scanning protocol after attending a structured training course. Assessment of anaesthesia trainees' competence and minimum training requirements were the aim of the study.
Detailed description
Point-of-care (POCUS) of the upper airway has proven a useful tool for airway management as well as diagnosis of upper airway pathology. Although anaesthesiologists are familiar with the use of ultrasound, with peripheral nerve blockade and vascular access representing the most popular applications in anaesthesiology, POCUS is not yet routinely used for airway evaluation. However, the reliability of such examination, which is clinician performed and interpreted, is highly dependent on the operator. Ultrasound-guided techniques require knowledge of sonoanatomy and ultrasound operational skills. Clinicians lack the standardized training that ultrasound technicians and radiologists receive. POCUS training is rarely done in a standardized manner, and even more so, POCUS is rarely conducted under expert's supervision. Insufficient ultrasonographic skills increase the risk of misdiagnosis compromising patient care.
This is a prospective observational study conducted in the University Hospital of Ioannina to investigate the feasibility of upper airway POCUS performed on healthy volunteers by anaesthesia residents using a predefined scanning protocol after attending a structured training course. Assessment of anaesthesia trainees' competence and minimum training requirements are the aim of the study.
All subjects will be healthy volunteer members of the Operating Room (OR) staff. The training course will be shaped in a stepwise manner, beginning with an "education day" that includes a didactic lecture and a hands-on workshop, followed by a "performance week" for competence assessment. During "education day" a predefined scanning protocol will be taught and practiced. An experienced in neck ultrasound radiologist (instructor) will demonstrate the scans and will supervise all trainees. The predefined scanning protocol includes identification of specific structures [(i) visualization of the hyoid bone, (ii) visualization of vocal cords, (iii) localization of thyrohyoid membrane and visualization of epiglottis and pre-epiglottic space, (iv) visualization of cricothyroid membrane, and (v) visualization of thyroid gland)], as well as performance of specific measurements [(i) distance from hyoid bone to skin, (ii) distance from anterior commissure to skin, (iii) distance from epiglottis to skin, and (iv) distance from thyroid isthmus to skin].
During "performance week" all trainees will perform upper airway POCUS to members of the OR staff. The predefined protocol will be applied in each case. A single scan will be allowed for each subject. All subjects will have ultrasound measurements recorded separately by the six trainees and the instructor. The data will be collected at bedside and each participant will be blinded to each other's assessments. Trainees' performance will be assessed by paired calculations of the trainee - instructor differences in all ultrasound measurements of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers, all members of the Operating Room (OR) staff, not anticipated to have difficult laryngoscopy and/or intubation based on their clinical upper airway evaluation.
Key inclusion criteria (1 listed)
- healthy adult volunteers (ASA physical status I and II)
Key exclusion criteria (4 listed)
- history of congenital or acquired airway abnormalities
- modified Simplified Airway Risk Index (SARI) > 4
- mallampati score > 3
- Body mass index (BMI) > 35 Kg/m2
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 |
|---|---|---|
| Visualization of the hyoid boneVisualization of the hyoid bone using POCUS of upper airway (probe positioning: transverse plane). Hyoid bone visualization will be assessed as a binary outcome (yes/no). | Other | – |
| Visualization of vocal cordsVisualization of the vocal cords through the cricoid cartilage using POCUS of upper airway (probe positioning: transverse plane). Vocal cords visualization will be assessed as a binary outcome (yes/no). | Other | – |
| Localization of thyrohyoid membraneLocalization of thyrohyoid membrane using POCUS of upper airway (probe positioning: midsagittal plane). Thyrohyoid membrane visualization will be assessed as a binary outcome (yes/no). | Other | – |
| Visualization of epiglottis and pre-epiglottic spaceVisualization of epiglottis and pre-epiglottic space using POCUS of upper airway (probe positioning: midsagittal plane). Epiglottis and pre-epiglottic space visualization will be assessed as a binary outcome (yes/no). | Other | – |
| Visualization of cricothyroid membraneVisualization of cricothyroid membrane using POCUS of upper airway (probe positioning: midsagittal plane). Cricothyroid membrane visualization will be assessed as a binary outcome (yes/no). | Other | – |
| Visualization of thyroid glandVisualization of thyroid gland using POCUS of upper airway (probe positioning: transverse plane). Thyroid gland visualization will be assessed as a binary outcome (yes/no). | Other | – |
| Hyoid bone to skin distanceMeasurement of hyoid bone to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane). | Other | – |
| Anterior commissure to skin distanceMeasurement of anterior commissure to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane). | Other | – |
| Epiglottis to skin distanceMeasurement of epiglottis to skin distance (mm) using POCUS of upper airway (probe positioning: midsagittal plane). | Other | – |
| Thyroid isthmus to skin distanceMeasurement of thyroid isthmus to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane). | Other | – |
Primary outcome
T-I differences for hyoid bone to skin distance
Time frame: 10 days
Paired calculations of trainee-instructor (T-I) differences (mm) for hyoid bone to skin distance.
T-I differences for anterior commissure to skin distance
Time frame: 10 days
Paired calculations of trainee-instructor (T-I) differences (mm) for anterior commissure to skin distance.
T-I differences for epiglottis to skin distance
Time frame: 10 days
Paired calculations of trainee-instructor (T-I) differences (mm) for epiglottis to skin distance.
T-I differences for thyroid isthmus to skin distance
Time frame: 10 days
Paired calculations of trainee-instructor (T-I) differences (mm) for thyroid isthmus to skin distance.
6 secondary outcomes
Hyoid bone visualization
Time frame: 10 days
Vocal cords visualization
Time frame: 10 days
Thyrohyoid membrane localization, epiglottis and pre-epiglottic space visualization
Time frame: 10 days
Cricothyroid membrane visualization
Time frame: 10 days
Thyroid gland visualization
Time frame: 10 days
Sanning duration
Time frame: 10 days
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 26 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Airway Management, run by University of Ioannina at 1 site in Greece.
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 4 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 26 Jul 2022. 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 Greece. 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?
T-I differences for hyoid bone to skin distance (time frame: 10 days). The study lists 4 primary outcomes in all. 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 26 Jul 2022.