Medical Errors : Wrong Site Surgery in Regional AnesthesiaELPSiteNCT03232840
E-learning to Prevent Wrong Site Surgery in Anesthesia
An observational study of Medical Errors : Wrong Site Surgery in Regional Anesthesia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Errors : Wrong Site Surgery in Regional Anesthesia
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2017to 31 Dec 2018
- 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: Patients undergoing anesthesia in Lapeyronie Hospital
Who may be able to join
- patient undergoing regional anesthesia with or without general anesthesia
Who cannot join
- general anesthesia without regional anesthesia
- perimedullar anesthesia
- bilateral surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- wrong site surgery in regional anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start31 Jul 2017
- Primary completion30 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Errors : Wrong Site Surgery in Regional AnesthesiaStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BIBOULET Philippe, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232840
- Sponsor's protocol ID
- RECHMPL17_0228
- Acronym
- ELPSite
- Status last verified
- Oct 2018
- First submitted
- 5 Jul 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an E-learning to Prevent Wrong Site Surgery in Anesthesia.
- ClinicalTrials.gov ID
- NCT03232840
- Acronym / sponsor ID
- ELPSite / RECHMPL17_0228
- Keywords
- wrong site surgery in regional anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Jul 2017 (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 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing anesthesia in Lapeyronie Hospital
Key inclusion criteria (1 listed)
- patient undergoing regional anesthesia with or without general anesthesia
Key exclusion criteria (3 listed)
- general anesthesia without regional anesthesia
- perimedullar anesthesia
- bilateral surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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 18 Apr 2019.
- Individual participant dataSharing planned: Undecided. NC
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.
BIBOULET Philippe, MD, PhD study director
University Hospital, Montpellier
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 Medical Errors : Wrong Site Surgery in Regional Anesthesia, run by University Hospital, Montpellier 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 3 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 18 Apr 2019. 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?
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). 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 18 Apr 2019.