Respiratory Failure Clinical Trial
Official title:
Training Thoracic Ultrasound Skills: a Multicentre, Blinded, Randomized Controlled Trial of Simulation-based Training Versus Training on Healthy Figurants
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.
Thoracic ultrasound (TUS) differs from ultrasound examinations in other organ systems,
because it is not possible in the healthy, ventilated lung to visualize structures or
anatomical parts of the lung, like it is when examining abdomen or performing an
echocardiography. It is therefore not possible to transfer results directly from educational
studies using simulation-based training in other areas of medicine, to thoracic ultrasound.
TUS examinations are considered safe, and without pain, exposure to radiation or delay of
patients' course, but ultrasound in general is highly operator dependent and lack of
theoretical knowledge or practical skills could potentially lead to incorrect diagnosis and
thus treatment. Therefore simulation-based training, theoretical and practical tests could be
the key to a "pre-trained novice" with a level of competency higher than a complete novice
when performing the first TUS examination on a patient in a clinical setting.
The objective of this trial is to examine whether TUS training on a simulator is superior to
training on healthy figurants, which today is a commonly used method for gaining skills and
competencies in TUS. 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 3 months
follow-up.
Methods The design is a three-armed, multicentre, blinded randomized controlled trial. The
trial takes place at three simulation centres at university hospitals in Denmark; Odense
University Hospital, Rigshospitalet, and Aarhus University Hospital. The intervention period
is scheduled to run from August 2018 to May 2019.
Participants All physicians employed at public hospitals in Region of Southern Denmark,
Capital Region of Denmark, Region Zealand, and Central Denmark Region, are eligible for
inclusion in the trial. Because physicians from a wide range of specialities can benefit from
TUS examinations, no exclusion criteria are established based on the specialities from the
physicians.
Trainees sign up for participation, and inclusion by mail, and will receive a reply including
information about the trial. Exclusion criteria are; lack of informed consent, physicians
with connection to the trial, or involvement in the design or conduction.
Prior to intervention Prior to the randomization all participants will complete an online
survery and educational programme in TUS in order to reach sufficient theoretical knowledge.
Included participants must pass a theoretical test.
All included participants will receive a study identification number that makes it possible
to pair the results from the questionnaire to the intervention and performances.
All materials needed prior to the theoretical test, including online educational material,
log-in to questionnaire and test will be send to the participants by mail. The online
educational material comprises access to Munksgaards' online e-portal in basic ultrasound.
The theoretical part is estimated to 2-3 hours. The theoretical test is administered in
Research Electronic Data Capture (REDCap) provided by Odense Patient data Explorative Network
(OPEN). Participants will be excluded if they do not complete the test.
Part two of the trial will take place in one of the simulation centres. All participants will
receive an introduction to the ultrasound machine. A medical student working on the project
will do the introduction. Subsequently the randomization is done in REDCap, which allows an
online, computer-generated allocation sequence concealed to the project leaders. The ratio is
1:1:1 with no stratification for site (location).
Trial intervention The trial intervention includes a new experimental educational approach;
in vitro simulation-based TUS training. The TUS module for the US Mentor Simulator is made in
collaboration with 3D Systems (3D Systems Healthcare, Littleton, USA, formerly known as
Simbionix).
This simulation model will serve as first intervention arm. The group randomized for
simulation-based training is allowed to practice for 2.5 hours prior to assessment. The
second intervention arm in the trial is the conventional hands-on training method;
examination of healthy volunteers (figurants), in this case medical students who signed up
for the job, and who is a part of the research group. Trainees are as well allowed to train
for up to 2.5 hours, and the medical students are not allowed to help or guide the trainee
during the examinations. Last group will not receive any hands-on training other than the
general information, and will serve as controls. Figure 1 present a flowchart of the trial.
When trainees have finished the hands-on training, they will continue to assessment of
competencies, done by an instructor blinded to the intervention. The assessment will take
place in the emergency department examining real patients suspected to have thoracic
pathology/pathologies. As assessment tool the LUS-OSAUS (Lung Ultrasound - Objective
Structured Assessment of Ultrasound Skills) score sheet is used. The assessment will be
repeated twice. The instructor assessing the participants is blinded to the intervention. The
data-managers providing the statistical analysis are going to be blinded when performing the
analyses and when drawing conclusions of the results.
Sample size and statistics Significance 5%, Power 90%, mean difference wanted between the two
interventional groups is 8.5 point. Standard deviation 8.67. Sample size per group = 22
(total; 66 participants).
Data will be accessed using OPEN analyse, and analysed using STATA and SPSS. OPEN Analyse
acts as terminal server solution from the researcher's private PC with logging if files, but
data are stored and processed on a server at the Regional IT.
A two-sided significance level of 0.05 will be used. Statistical methods for the primary and
secondary outcomes are presented in Table 1, and include Post Hoc ANOVA with Bonferroni
correction, hands-on training facility as independent variable (SIM, FIG, controls), and
LUS-OSAUS scores as dependent variable.
All data will be analysed as intention to treat, therefore missing data will be handled by
multiple imputation technique, even though missing data are expected to be minimal because
instructors are registering a great amount of the data to the database.
Ethical considerations The patient scanned at the assessment will be given oral information
about the trial including aim, running and assessment of participants, and that ultrasound is
a non-invasive and radiation-free radiological examination with no risk of complications or
side effects. Subsequent, orally informed consent will be given from the patient. If the
ultrasound examination provides further information to the patient inquiry, which is
suspected as new information, the physician in charge of the patient will be informed orally.
The trial complies with the Declaration of Helsinki on biomedical research and with the act
on processing personal data. The Regional Committees on Health Research Ethics for Southern
Denmark has been given the project description and protocol, and found that in accordance to
Danish regulations, ethical approval is not required for carrying out the trial
(S-20172000-44).
The trial is notified to the Danish Data Protection Agency under the in Region of Southern
Denmark, and, as prescribed, a data management contract is going to be signed with authors
and supervisors outside the region.
Discussion The presented trial is set to investigate whether a TUS simulator as hands-on
training facility, can provide a higher level of competencies after 2.5 hour training, than
training on healthy figurants, which is a commonly used model today.
Simulation-based medical education (SBME) has several advantages, and is a complex
educational intervention that enables both immersive and experimental learning, and makes it
possible to acquire and maintain skills in a calm and safe environment without putting
patients at risk if a wrong decision or interpretation is made. The use of this approach has
increased within the last decade, and in various specialities using technical procedures.
Furthermore, all pathologies considered mandatory to the content or course are possible to
explore, and a trainee is able to practice a particular case or high-risk cases, over and
over again, if doubt arises or if the trainee does not provide a satisfying result. Seen in a
research perspective, SBME makes it possible to compare results of different trainees for
research purpose, because of a standardized set-up. On the other hand, disadvantages in
simulation training appear; e.g. if the fidelity drops for a short moment, the trainee may
use a lot of effort to move back into the simulation setting, the technical models require
updates, maintenance, and an instructor is often necessary in the beginning for introduction,
and for emphasizing trainee reflection and peer review elements. Last, but not least
simulation training cannot replace traditional apprenticeship or stand alone, but must be
seen as and add-on approach prior to supervised training in a clinical setting.
Today in TUS, it is often a fixed number of examinations on patients that determines whether
a physician can do a sufficient ultrasound examination sufficiently. Otherwise a supervisor,
subjectively, accepts and approves a trainee's skills, but none of those methods ensure the
professional level of competencies, and can be affected by external factors and cause
feasibility problems. There will be situations where a patient is seriously ill, and rapid
start of treatment is basis for a good outcome. In these situations education is not first
priority, and is easily put in line.
Secondly, due to the varying incidence of various pulmonary diseases and pathologies,
hands-on training on patients in a clinical setting does not ensure examination of all
important sonographic findings.
To our knowledge no previous studies have been published, comparing the effects of different
hands-on training facilities in TUS. Several studies have shown a positive effect of one
particular modality, e.g. laboratory animals, cadavers, phantoms, or like in this trial,
healthy figurants or simulators, but did not compare the effects.
Previous studies that have investigated simulation training in ultrasound of other organ
systems than lungs or thorax, or ultrasound guided procedures, have showed large and
significant effect when compared to no training, but in order to provide realistic and
transferable comparison the control group should not be no training, but training as is the
case today; training on healthy figurants. In order to implement simulation training for
gaining TUS competencies, and rethink the educational tasks for physicians, the results for
the simulator group are expected to be better than the group of comparison and controls.
Limitations The study will suffer from a number of limitations. Given the nature of the trial
it is not possible to blind the participants, but the instructor assessing the participant is
blinded to the intervention. During the analyses and reporting, the allocation will be
blinded to the data-managers.
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