Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05466409 |
| Other study ID # |
942 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 29, 2021 |
| Est. completion date |
December 13, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
University of Ioannina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
