NCT05466409

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

7 days

First QC Date

July 17, 2022

Last Update Submit

July 21, 2022

Conditions

Keywords

TrainingPoint-of-care-ultrasound

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Hyoid bone visualization

    10 days

  • Vocal cords visualization

    10 days

  • Thyrohyoid membrane localization, epiglottis and pre-epiglottic space visualization

    10 days

  • Cricothyroid membrane visualization

    10 days

  • Thyroid gland visualization

    10 days

  • +1 more secondary outcomes

Interventions

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 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 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 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 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 using POCUS of upper airway (probe positioning: transverse plane). Thyroid gland visualization will be assessed as a binary outcome (yes/no).

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

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

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univesity Hospital of Ioannina

Ioannina, Epirus, 45110, Greece

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anaesthesiology

Study Record Dates

First Submitted

July 17, 2022

First Posted

July 20, 2022

Study Start

November 29, 2021

Primary Completion

December 6, 2021

Study Completion

December 13, 2021

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations