Tracheobronchial AnomaliesSIMREALNCT03485521
Interest of Simulation as Part of the Procedure Tracheobronchial Aspiration
A study testing The tracheobronchial aspiration in people with Tracheobronchial Anomalies, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The aim of this study is to compare a control group (Practical Work Group) with a High fidelity Stimulation group about competences and reasoning clinic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tracheobronchial Anomalies
- What is being tested?
- The tracheobronchial aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2017to 13 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Learners: All second year students enrolled in initial training of the Institute of kinesitherapy of Toulouse during the year 2017-2018. In total 45 students.
- Patients :All adult patients with tracheotomy, and able to communicate. Patients hospitalized in the University Hospital de Toulouse
Who cannot join
- Learners: Students absent on the day of the reading of the procedures
- Patients:Adolescent patients, child patients, Patients with a communication deficit, Patients under respirators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of High Fidelity Simulation Training Beginning as Part of the Procedure Tracheobronchial Aspiration
The aim of this study is to compare a control group (Practical Work Group) with a High fidelity Stimulation group about competences and reasoning clinic.
Read the detailed description
Health simulation is in full development on the national territory (France). The medical profession and nurses use this mode of learning in initial training to improve the students skills The report of Pr Granry allowed an inventory of the simulation in France with as Leitmotiv "never the first time for the patient". It has also put in place priorities for the coming years, one of which is to develop simulation in initial and in-service training. This learning technique is interesting according to several parameters. First,is the safety of care. A novice who has already practiced on a mannequin or in the context of the simulation will be able to better understand the situation of care in the clinical field. The quality of care is also improved by the practice of simulation including communication skills, psychomotor skills, respect for procedures and theoretical knowledge. This more or less faithful reproduction is all the more necessary as the duration of clinical placements is decreasing. Simulation is a way to mitigate this lack is allows a faithful immersion in the care environment. Despite all these positive points, physiotherapy is not yet very affected by the simulation as shown in the literature Gordon's review (2015). Initial training, continuing education has not to this day largely developed this teaching method . Some timid uses have taken place and for the most part in Anglo-Saxon countries with various modes of simulation. In France, certainly linked to the specificity of the profession, its implementation is delicate, even complicated. It remains anecdotal to this day.
- Conditions
- Tracheobronchial Anomalies
- Being tested
- The tracheobronchial aspiration
- Keywords
- High Fidelity Simulation Training, physiotherapy, tracheobronchial aspiration.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The tracheobronchial aspirationProcedure or surgery
Reading of the procedures of the tracheobronchial aspiration (legislative framework, rules of hygiene, procedures, undesirable effects) The Practical Group participates in a practical work lasting two hours and the Stimulation Group is in simulation with a procedural practice of tracheobronchial suction as part of a simulation sequence. This group benefits from the methodology of the simulation with a part of briefing, a part simulated session and to finish the debriefing.
The experiment finished with a real activity on patients with tracheotomy with in this environment the reproduction of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Practical Work | Active comparator | 15 students who participate in a practical work lasting two hours about the procedures of the tracheobronchial aspiration Receives: Procedure: The tracheobronchial aspiration |
| Stimulation Group | Experimental | Group with competences and reasoning clinic 15 students Simulation with a procedural practice of tracheobronchial suction as part of a simulation sequence after reading the procedures of the tracheobronchial aspiration Receives: Procedure: The tracheobronchial aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the acquisition of the skills of a tracheobronchial aspiration procedure
Evaluate the acquisition of the skills of a tracheobronchial aspiration procedure by an audit grid learning according to two different groups (Stimulation group and Practical Work group), on a learner population in initial formation of Institut physiotherapy.
Measured: Two hours
Secondary outcomes (1)
Compare the components of clinical reasoning : self-confrontation and simulation
Compare the components of clinical reasoning in different training typologies : practical work by using simple self-confrontation and simulation The simulation is filmed to watch the action of the learner after with him and bring out the implicit part of the student's clinical reasoning during the performance of the act (self-confrontation).
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start13 Nov 2017
- Primary completion13 Jan 2018
- Study completion13 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheobronchial AnomaliesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a pilot study, monocentric with randomization of para-medical personnel The randomization list is established by the researcher before the search begins. The strengths of the 3 treatment groups are balanced (15 per group). A document describing the randomization procedure is kept confidential.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Alain, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485521
- Sponsor's protocol ID
- RC31/17/0156
- Other IDs
- 2017-A01609-44
- Acronym
- SIMREAL
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of High Fidelity Simulation Training Beginning as Part of the Procedure Tracheobronchial Aspiration
- ClinicalTrials.gov ID
- NCT03485521
- Acronym / sponsor ID
- SIMREAL / RC31/17/0156
- Conditions
- Tracheobronchial Anomalies
- Keywords
- High Fidelity Simulation Training, physiotherapy, tracheobronchial aspiration.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 13 Jan 2018 (actual)
- Study completion
- 13 Jan 2018 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare a control group (Practical Work Group) with a High fidelity Stimulation group about competences and reasoning clinic.
Detailed description
Health simulation is in full development on the national territory (France). The medical profession and nurses use this mode of learning in initial training to improve the students skills The report of Pr Granry allowed an inventory of the simulation in France with as Leitmotiv "never the first time for the patient". It has also put in place priorities for the coming years, one of which is to develop simulation in initial and in-service training. This learning technique is interesting according to several parameters. First,is the safety of care. A novice who has already practiced on a mannequin or in the context of the simulation will be able to better understand the situation of care in the clinical field. The quality of care is also improved by the practice of simulation including communication skills, psychomotor skills, respect for procedures and theoretical knowledge. This more or less faithful reproduction is all the more necessary as the duration of clinical placements is decreasing. Simulation is a way to mitigate this lack is allows a faithful immersion in the care environment. Despite all these positive points, physiotherapy is not yet very affected by the simulation as shown in the literature Gordon's review (2015). Initial training, continuing education has not to this day largely developed this teaching method . Some timid uses have taken place and for the most part in Anglo-Saxon countries with various modes of simulation. In France, certainly linked to the specificity of the profession, its implementation is delicate, even complicated. It remains anecdotal to this day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- It is a pilot study, monocentric with randomization of para-medical personnel The randomization list is established by the researcher before the search begins. The strengths of the 3 treatment groups are balanced (15 per group). A document describing the randomization procedure is kept confidential.
| Arm | Type | Receives |
|---|---|---|
| Practical Work | Active comparator | Procedure: The tracheobronchial aspiration15 students who participate in a practical work lasting two hours about the procedures of the tracheobronchial aspiration |
| Stimulation Group | Experimental | Procedure: The tracheobronchial aspirationGroup with competences and reasoning clinic 15 students Simulation with a procedural practice of tracheobronchial suction as part of a simulation sequence after reading the procedures of the tracheobronchial aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Learners: All second year students enrolled in initial training of the Institute of kinesitherapy of Toulouse during the year 2017-2018. In total 45 students.
- Patients :All adult patients with tracheotomy, and able to communicate. Patients hospitalized in the University Hospital de Toulouse
Key exclusion criteria (2 listed)
- Learners: Students absent on the day of the reading of the procedures
- Patients:Adolescent patients, child patients, Patients with a communication deficit, Patients under respirators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The tracheobronchial aspirationReading of the procedures of the tracheobronchial aspiration (legislative framework, rules of hygiene, procedures, undesirable effects) The Practical Group participates in a practical work lasting two hours and the Stimulation Group is in simulation with a procedural practice of tracheobronchial suction as part of a simulation sequence. This group benefits from the methodology of the simulation with a part of briefing, a part simulated session and to finish the debriefing. The experiment finished with a real activity on patients with tracheotomy with in this environment the reproduction of the procedure | Procedure or surgery | Practical Work, Stimulation Group |
Primary outcome
Evaluate the acquisition of the skills of a tracheobronchial aspiration procedure
Time frame: Two hours
Evaluate the acquisition of the skills of a tracheobronchial aspiration procedure by an audit grid learning according to two different groups (Stimulation group and Practical Work group), on a learner population in initial formation of Institut physiotherapy.
1 secondary outcome
Compare the components of clinical reasoning : self-confrontation and simulation
Time frame: Two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Alain, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The tracheobronchial aspiration in people with Tracheobronchial Anomalies, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the acquisition of the skills of a tracheobronchial aspiration procedure (time frame: Two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.