Education and Training Competences in Thoracic Ultrasound

NCT03728491 | Unknown DMC

• 1 other identifier: OP_640
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Dyspnea; Pleural Effusion; Pulmonary Edema; Pneumothorax

Keywords

Medical Education; Simulation-based training; Ultrasonography; Thoracic imaging

Outcome Measures

Primary Outcomes (1)

• Difference in LUS-OSAUS score

  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.

  3 months (on the day of practical assessment, maximum 3 months after inclusion)

Secondary Outcomes (2)

• Time used for hands-on training

  3 months (on the day of practical assessment, maximum 3 months after inclusion)

• Number of performed examinations

  4 months after day of practical assessment

Study Arms (3)

Healthy Figurant

EXPERIMENTAL

Hands-on training on healthy figurants for gaining competence in TUS

Device: Healthy figurants

Simulator

EXPERIMENTAL

Hands-on training on US Mentor simulator for gaining competence in TUS

Device: Simulator

Controls

NO INTERVENTION

Controls with no hands-on training

Interventions

Simulator DEVICE

US Mentor simulator, lung module, provided by 3D Healthcare Systems

Also known as: US Mentor, by 3D Healthcare Systems

Simulator

Healthy figurants DEVICE

Medical students or volunteers without any pathology in thorax

Healthy Figurant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Physicians with no previous experience in thoracic ultrasound

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Regional Center for Technical Simulation

Odense C, 5000, Denmark

RECRUITING

Related Publications (21)

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  PMID: 26162895 BACKGROUND

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MeSH Terms

Conditions

Respiratory Insufficiency; Dyspnea; Pleural Effusion; Pulmonary Edema; Pneumothorax

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pleural Diseases; Lung Diseases

Study Officials

• Pia Iben B Pietersen, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pia Iben Pietersen, MD

CONTACT

0045 20605630; pia.iben.pietersen3@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phd-student

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: November 2, 2018
• Study Start: October 31, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)