TimeOPTISSNCT03738371
Formation of Health Professionals Through in Situ Simulation to Improve Performances During the Initial Step of Thrombectomy for Ischemic Strokes
An observational study of Time and Benefit of in Situ Simulation for This Kind of Training, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The thrombectomy is an emergency care provided as soon as possible to selected patients suffering from ischemic strokes. Many steps are necessary to prepare this specialized procedure of interventional neuroradiology, including installation and preparation of the patient for this act. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Time, Benefit of in Situ Simulation for This Kind of Training, Installation of the Patient Until the Percutaneous
- What is being tested?
- In situ simulation
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to 1 Dec 2019
- Phase
- Observational
- 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
Study population: health professionals
Who may be able to join
- voluntary professionals
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital neurologique, Centre Hospitalier Universitaire
Lyon
Lionel BAPTESTE, MD, 0472357944 ext. +33, lionel.bapteste@chu-lyon.fr
Lionel BAPTESTE, MD
About this study
Official title: Optimization of Performances During Thrombectomy Through In Situ Simulation
The thrombectomy is an emergency care provided as soon as possible to selected patients suffering from ischemic strokes. Many steps are necessary to prepare this specialized procedure of interventional neuroradiology, including installation and preparation of the patient for this act. This first and essential time required the intervention of many health professionals.
The approach consists of a series of formation through in situ simulations for these health professionals, in order to improve and optimize this first step of the procedure (from the installation of the patient to the percutaneous punch by the neuroradiologist).
- Conditions
- Time, Benefit of in Situ Simulation for This Kind of Training, Installation of the Patient Until the Percutaneous
- Being tested
- In situ simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In situ simulationOther
Team involved in thrombectomy procedures will be trained by in situ simulation. Simulation will reproduce the initial step of a thrombectomy procedure, i.e from from the installation of the patient to the percutaneous punch by the neuroradiologist. Simulation will be followed by a debriefing focused on the team performance. Three in situ simulation sessions will be realized by each team.
| Study group | Role | What they receive |
|---|---|---|
| Team of health professionals | Team of health professionals involved in thrombectomy (including specialized nurses in anesthesiology, anesthesiologists, neuroradiologist and technicians specialized in electro-radiology) will participate to in situ simulation. Receives: Other: In situ simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the team
Performance of the team will be scored using a technical and non-technical skill.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2018
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TimeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel BAPTESTE, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738371
- Sponsor's protocol ID
- OPTISS
- Acronym
- OPTISS
- Status last verified
- Nov 2018
- First submitted
- 28 Sep 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Performances During Thrombectomy Through In Situ Simulation
- ClinicalTrials.gov ID
- NCT03738371
- Acronym / sponsor ID
- OPTISS / OPTISS
- Conditions
- Time, Benefit of in Situ Simulation for This Kind of Training, Installation of the Patient Until the Percutaneous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 13 Nov 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 thrombectomy is an emergency care provided as soon as possible to selected patients suffering from ischemic strokes. Many steps are necessary to prepare this specialized procedure of interventional neuroradiology, including installation and preparation of the patient for this act. This first and essential time required the intervention of many health professionals.
The approach consists of a series of formation through in situ simulations for these health professionals, in order to improve and optimize this first step of the procedure (from the installation of the patient to the percutaneous punch by the neuroradiologist).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Team of health professionals | – | Other: In situ simulationTeam of health professionals involved in thrombectomy (including specialized nurses in anesthesiology, anesthesiologists, neuroradiologist and technicians specialized in electro-radiology) will participate to in situ simulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- health professionals
Key inclusion criteria (1 listed)
- voluntary professionals
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| In situ simulationTeam involved in thrombectomy procedures will be trained by in situ simulation. Simulation will reproduce the initial step of a thrombectomy procedure, i.e from from the installation of the patient to the percutaneous punch by the neuroradiologist. Simulation will be followed by a debriefing focused on the team performance. Three in situ simulation sessions will be realized by each team. | Other | Team of health professionals |
Primary outcome
Performance of the team
Time frame: 12 months
Performance of the team will be scored using a technical and non-technical skill.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
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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.
Lionel BAPTESTE, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Time and Benefit of in Situ Simulation for This Kind of Training, run by Hospices Civils de Lyon 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 13 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lionel BAPTESTE, MD (0472357944 ext. +33, lionel.bapteste@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the team (time frame: 12 months). 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 13 Nov 2018.