Education and Training Competences in Thoracic Ultrasound
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03728491|
Recruitment Status : Unknown
Verified March 2019 by Pia Iben Pietersen MD, Odense University Hospital.
Recruitment status was: Recruiting
First Posted : November 2, 2018
Last Update Posted : March 25, 2019
The use of thoracic ultrasound has expanded widely within the las couple of years, and several studies have proved a high diagnostic accuracy for many of the most common causes of respiratory failure and dyspnoea.
The ultrasound scan is a bed-side, and dynamic examination, which demands sufficient theoretical and practical knowledge and competence by the operator, but so far, no studies have explored the effect of simulation-based training for gaining adequate competence compared to traditional hands-on training on healthy figurants.
The aim of this study is to examine whether TUS training on a simulator is superior to training on healthy figurants. Secondly, to examine whether the choice of hands-on training has an effect on the number of examinations performed by the trainees from baseline to 4 months follow-up.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure Dyspnea Pleural Effusion Pulmonary Edema Pneumothorax||Device: Simulator Device: Healthy figurants||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Training Thoracic Ultrasound Skills: a Multicentre, Blinded, Randomized Controlled Trial of Simulation-based Training Versus Training on Healthy Figurants|
|Actual Study Start Date :||October 31, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Experimental: Healthy Figurant
Hands-on training on healthy figurants for gaining competence in TUS
Device: Healthy figurants
Medical students or volunteers without any pathology in thorax
Hands-on training on US Mentor simulator for gaining competence in TUS
US Mentor simulator, lung module, provided by 3D Healthcare Systems
Other Name: US Mentor, by 3D Healthcare Systems
No Intervention: Controls
Controls with no hands-on training
- Difference in LUS-OSAUS score [ Time Frame: 3 months (on the day of practical assessment, maximum 3 months after inclusion) ]
Difference in assessment score (Lung Ultrasound Objective Structured Assessment of Ultrasound Skills score) between the three groups (total score).
The scale comprises 17 items with a score from 1-5 in each. Minimum 17, maximum 85, meaning that a score of 85 point is the best possible ultrasound examination.
- Time used for hands-on training [ Time Frame: 3 months (on the day of practical assessment, maximum 3 months after inclusion) ]Time used for hands-on training between the two interventional groups (minutes)
- Number of performed examinations [ Time Frame: 4 months after day of practical assessment ]Number of performed examinations from baseline to 4 months follow up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728491
|Contact: Pia Iben Pietersen, MD||0045 email@example.com|
|Principal Investigator:||Pia Iben B Pietersen, MD||Odense University Hospital|