NCT03738371

Brief 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

Same day

First QC Date

September 28, 2018

Last Update Submit

November 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance of the team

    Performance of the team will be scored using a technical and non-technical skill.

    12 months

Study Arms (1)

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.

Other: In situ simulation

Interventions

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.

Team of health professionals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

health professionals

You may qualify if:

  • voluntary professionals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital neurologique, Centre Hospitalier Universitaire

Lyon, France

RECRUITING

Study Officials

  • Lionel BAPTESTE, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lionel BAPTESTE, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2018

First Posted

November 13, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2018

Study Completion

December 1, 2019

Last Updated

November 13, 2018

Record last verified: 2018-11

Locations