Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
22 participants
OBSERVATIONAL
2021-11-29
2021-12-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Upper Airway Ultrasound Evaluation
NCT06701253
Sonographic Evaluation to Predict Difficult Airway Management
NCT03991325
Ultrasound to Predict Difficult Airway
NCT03789071
POCUS ASSESSMENT FOR TRACHEAL VS OESOPHAGEAL INTUBATION
NCT05983666
Two Neck Ultrasound Measurements as Predictors of Difficult Laryngoscopy
NCT03547193
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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).
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).
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).
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).
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).
Hyoid bone to skin distance
Measurement of hyoid bone to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane).
Anterior commissure to skin distance
Measurement of anterior commissure to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane).
Epiglottis to skin distance
Measurement of epiglottis to skin distance (mm) using POCUS of upper airway (probe positioning: midsagittal plane).
Thyroid isthmus to skin distance
Measurement of thyroid isthmus to skin distance (mm) using POCUS of upper airway (probe positioning: transverse plane).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* modified Simplified Airway Risk Index (SARI) \> 4
* mallampati score \> 3
* Body mass index (BMI) \> 35 Kg/m2
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Ioannina
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Agathi Karakosta
Assistant Professor of Anaesthesiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univesity Hospital of Ioannina
Ioannina, Epirus, Greece
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
942
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.