Plain English Summary
Background and study aims
Appropriate sedation is a crucial part for a successful gastrointestinal (GI) procedure (surgery on the digestive system). Sedation for GI procedures is mostly done by the gastroenterologist in charge. However, many of them do not have the training required to prevent possible complications or side effects. Simulation has proven to be an excellent teaching tool for teaching both technical and non-technical skills, communication, crisis management and improving patient safety.
The aim of this study was to test the impact of anesthesiologist (doctors that administer local or general anesthetic during surgery) led simulation sessions on sedation for GI procedures done by non-anesthesiologists.
Who can participate?
Medical doctors aged between 25-65 and undergoing endoscopic procedures.
What does the study involve?
Each participant is observed while they perform 15 consecutive endoscopic procedures. They then attend a simulation training course about sedation for endoscopic procedures. Finally, they are all observed again while they perform another 15 endoscopic procedures.
What are the possible benefits and risks of participating?
The participants in this study may improve their knowledge and skills in sedating patients when performing endoscopic procedures. There are no risks associated with taking part in the study.
Where is the study run from?
Catholic University of Chile, Christus Clinical Hospital (Chile)
When is the study starting and how long is it expected to run for?
April 2013 to October 2015
Who is funding the study?
National Commission for Scientific and Technological Research (Chile)
Who is the main contact?
Mr Alejandro Delfino
Trial website
Contact information
Type
Scientific
Primary contact
Mr Alejandro Delfino
ORCID ID
http://orcid.org/0000-0002-0659-7130
Contact details
Marcoleta 367
Santiago
8330024
Chile
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The use of simulation to improve patients' security under sedation in endoscopic procedures
Acronym
Study hypothesis
The introduction of a practical teaching course about sedation based on simulation can improve the sedation's quality and the patients´ security.
Ethics approval
Ethics committee at Catholic University of Chile (Pontificia Universidad Catolica de Chile), 06/08/2013
Study design
Prospective interventional single-centre non randomised clinical trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Sedation
Intervention
A group of 10 endoscopists were prospectively observed during 15 consecutive endoscopic procedures. After that, all subjects attended a simulation teaching course about sedation for endoscopic procedures. Finally, the same subjects were prospectively observed during 15 endoscopic procedures.
The simulation teaching course:
Three high-fidelity simulation cases (upper airway obstruction, agitation and hemodynamic instability) were designed according to the essential elements of the checklist. Each session consisted of a detailed prebriefing, followed by one simulation case. After each scenario, a trained instructor guided a debriefing session focused on technical and nontechnical skills performance.
Three months after the intervention the gastroenterologists’ sedation performance was re-evaluated with the use of the checklist. Differences before/after the intervention was calculated using the McNemar’s test. A p ≤ 0.05 was considered significant.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Patients sedations' quality under endoscopic procedures. To measure this an specific checklist was developed. This instrument was used pre and three month after the intervention
2. Knowledge about sedation: this was measured pre and three month after the intervention using a specific multiple choice question test
Secondary outcome measures
Serious adverse events: a comparison was performed between the institution historic register of adverse events between January 2010 and December 2013 and the prospective register from the studied population during nine month after the intervention.
Overall trial start date
05/04/2013
Overall trial end date
12/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Medical doctors who perform endoscopic procedures
2. Aged 25 to 65 years
3. Agreed to participate in the simulation sessions
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
10 participants
Participant exclusion criteria
Participants that don't fulfill the inclusion criteria
Recruitment start date
05/04/2013
Recruitment end date
12/04/2015
Locations
Countries of recruitment
Chile
Trial participating centre
Catholic University of Chile (Pontificia Universidad Catolica de Chile)
Christus Clinical Hospital
Marcoleta 367
Santiago
8330024
Chile
Funders
Funder type
Government
Funder name
Comisión Nacional de Investigación Científica y Tecnológica
Alternative name(s)
National Commission for Scientific and Technological Research, CONICYT
Funding Body Type
government organisation
Funding Body Subtype
federal
Location
Chile
Results and Publications
Publication and dissemination plan
During the present year I will submit the original paper to one journal dedicated preferentially to endoscopic procedures.
Intention to publish date
31/12/2016
Participant level data
Available on request
Basic results (scientific)
Publication list