Upper Airway Ultrasound Training Requirements

NCT ID: NCT05466409

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2021-12-13

Brief Summary

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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

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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

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Airway Management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Visualization of the hyoid bone

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).

Intervention Type OTHER

Visualization of vocal cords

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).

Intervention Type OTHER

Localization of thyrohyoid membrane

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).

Intervention Type OTHER

Visualization of epiglottis and pre-epiglottic space

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).

Intervention Type OTHER

Visualization of cricothyroid membrane

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).

Intervention Type OTHER

Visualization of thyroid gland

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).

Intervention Type OTHER

Hyoid bone to skin distance

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

Intervention Type OTHER

Anterior commissure to skin distance

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

Intervention Type OTHER

Epiglottis to skin distance

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

Intervention Type OTHER

Thyroid isthmus to skin distance

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Agathi Karakosta

Assistant Professor of Anaesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Univesity Hospital of Ioannina

Ioannina, Epirus, Greece

Site Status

Countries

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Greece

Other Identifiers

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942

Identifier Type: -

Identifier Source: org_study_id

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