- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03232840
E-learning to Prevent Wrong Site Surgery in Anesthesia (ELPSite)
April 17, 2019 updated by: University Hospital, Montpellier
Evaluation of an E-learning to Prevent Wrong Site Surgery in Anesthesia.
The purpose of this observational study is to assess the efficiency of an e-learning in order to put into practice some preventive measures to avoid wrong site surgery during anesthesia.
Study Overview
Status
Completed
Detailed Description
Before the study, the investigators selected 7 preventive measures to avoid wrong site surgery during regional anesthesia combined or not with general anesthesia .
These measures were learned to the entire anesthesia team (nurse, resident and anesthesiologist) during conventional meetings.
An initial evaluation of the application of these measures will be carried out before the introduction of e-learning.
This assessment will be conducted by nurses without the knowledge of the anesthetic team evaluated.
After this initial evaluation, e-learning will be broadcast on the hospital intranet.
Then a second evaluation of the application of the preventive measures will be carried out 6 month and 1 year after the introduction of e-learning.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Uhmontpellier
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing anesthesia in Lapeyronie Hospital
Description
Inclusion criteria:
- patient undergoing regional anesthesia with or without general anesthesia
Exclusion criteria:
- general anesthesia without regional anesthesia
- perimedullar anesthesia
- bilateral surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the application of each of the 7 preventive measures using a questionnaire filled by a nurse not involved in the regional anesthesia procedure
Time Frame: 1 day
|
Evaluation of the application of each of the 7 preventive measures using a questionnaire filled by a nurse not involved in the regional anesthesia procedure.
This questionnaire simply indicates whether a measure has been applied or not
|
1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the application of each of the 7 preventive measures according to various clinical parameters
Time Frame: 1 day
|
Evaluation of the application of each of the 7 preventive measures according to the clinical parameters of the patients followed (age of the patient, ASA physical status, type of surgery, type of anesthesia, period of the day or week, Emergency or elective).
|
1 day
|
Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.
Time Frame: 6 month and 1 year
|
Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.
|
6 month and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: BIBOULET Philippe, MD, PhD, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2017
Primary Completion (Actual)
October 30, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
July 5, 2017
First Submitted That Met QC Criteria
July 25, 2017
First Posted (Actual)
July 28, 2017
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 17, 2019
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- RECHMPL17_0228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.