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Completed

NCT Number: NCT05466409

Upper Airway Ultrasound Training Requirements

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univesity Hospital of Ioannina

Ioannina, Epirus, 45110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visualization of the hyoid bone

Other

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 cords

Other

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 membrane

Other

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 space

Other

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 membrane

Other

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 gland

Other

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 distance

Other

Measurement of hyoid bone to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane).

Anterior commissure to skin distance

Other

Measurement of anterior commissure to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane).

Epiglottis to skin distance

Other

Measurement of epiglottis to skin distance (mm) using POCUS of upper airway (probe positioning: midsagittal plane).

Thyroid isthmus to skin distance

Other

Measurement of thyroid isthmus to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Hyoid bone visualization

    Time frame: 10 days

    Success rate (%) for hyoid bone visualization using upper airway POCUS (transverse plane).

  2. Vocal cords visualization

    Time frame: 10 days

    Success rate (%) for vocal cords visualization using upper airway POCUS (transverse plane).

  3. Thyrohyoid membrane localization, epiglottis and pre-epiglottic space visualization

    Time frame: 10 days

    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).

  4. Cricothyroid membrane visualization

    Time frame: 10 days

    Success rate (%) for cricothyroid membrane visualization using upper airway POCUS (midsagittal plane).

  5. Thyroid gland visualization

    Time frame: 10 days

    Success rate (%) for thyroid gland visualization using upper airway POCUS (transverse plane).

  6. Sanning duration

    Time frame: 10 days

    Total duration (seconds) of the predefined scanning protocol.

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

Training Requirements in Point of Care Ultrasonography of the Upper Airway. A Feasibility Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2022
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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