Upper Airway Ultrasound Training Requirements

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Other: Visualization of the hyoid bone; Other: Visualization of vocal cords; Other: Localization of thyrohyoid membrane; Other: Visualization of epiglottis and pre-epiglottic space; Other: Visualization of cricothyroid membrane; Other: Visualization of thyroid gland; Other: Hyoid bone to skin distance; Other: Anterior commissure to skin distance; Other: Epiglottis to skin distance; Other: Thyroid isthmus to skin distance

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Greece
  • Epirus
    • Ioannina, Epirus, Greece, 45110
      • Univesity Hospital of Ioannina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

- healthy adult volunteers (ASA physical status I and II)

Exclusion Criteria:

• history of congenital or acquired airway abnormalities
• modified Simplified Airway Risk Index (SARI) > 4
• mallampati score > 3
• Body mass index (BMI) > 35 Kg/m2

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T-I differences for hyoid bone to skin distance	Paired calculations of trainee-instructor (T-I) differences (mm) for hyoid bone to skin distance.	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.	10 days
T-I differences for epiglottis to skin distance	Paired calculations of trainee-instructor (T-I) differences (mm) for epiglottis to skin distance.	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.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyoid bone visualization	Success rate (%) for hyoid bone visualization using upper airway POCUS (transverse plane).	10 days
Vocal cords visualization	Success rate (%) for vocal cords visualization using upper airway POCUS (transverse plane).	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).	10 days
Cricothyroid membrane visualization	Success rate (%) for cricothyroid membrane visualization using upper airway POCUS (midsagittal plane).	10 days
Thyroid gland visualization	Success rate (%) for thyroid gland visualization using upper airway POCUS (transverse plane).	10 days
Sanning duration	Total duration (seconds) of the predefined scanning protocol.	10 days

Collaborators and Investigators

• Sponsor: University of Ioannina

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): December 6, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Training; Point-of-care-ultrasound
• Other Study ID Numbers: 942

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No