Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03728491
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pia Iben Pietersen MD, Odense University Hospital

Brief Summary:

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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Training Thoracic Ultrasound Skills: a Multicentre, Blinded, Randomized Controlled Trial of Simulation-based Training Versus Training on Healthy Figurants
Estimated Study Start Date : October 31, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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

Experimental: Simulator
Hands-on training on US Mentor simulator for gaining competence in TUS
Device: Simulator
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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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)

  2. Number of performed examinations [ Time Frame: 4 months after day of practical assessment ]
    Number of performed examinations from baseline to 4 months follow up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physicians with no previous experience in thoracic ultrasound

Exclusion Criteria:

  • Physicians with relation to the trial or study
  • Physicians with previous experience in thoracic ultrasound
  • Physicians who do not provide written consent

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Pia Iben Pietersen, MD 0045 20605630 pia.iben.pietersen3@rsyd.dk

Sponsors and Collaborators
Odense University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Pia Iben B Pietersen, MD Odense University Hospital
  Study Documents (Full-Text)

Documents provided by Pia Iben Pietersen MD, Odense University Hospital:

Publications:

Layout table for additonal information
Responsible Party: Pia Iben Pietersen MD, MD, phd-student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03728491     History of Changes
Other Study ID Numbers: OP_640
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pia Iben Pietersen MD, Odense University Hospital:
Medical Education
Simulation-based training
Ultrasonography
Thoracic imaging

Additional relevant MeSH terms:
Layout table for MeSH terms
Pleural Effusion
Respiratory Insufficiency
Dyspnea
Pneumothorax
Pulmonary Edema
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pleural Diseases
Lung Diseases