Simulation can improve patients' security in endoscopic procedures

ISRCTN ISRCTN11222101
DOI https://doi.org/10.1186/ISRCTN11222101
Secondary identifying numbers N/A
Submission date
01/02/2016
Registration date
02/02/2016
Last edited
02/02/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Alejandro Delfino
Scientific

Marcoleta 367
Santiago
8330024
Chile

ORCiD logoORCID ID 0000-0002-0659-7130

Study information

Study designProspective interventional single-centre non randomised clinical trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe use of simulation to improve patients' security under sedation in endoscopic procedures
Study objectivesThe introduction of a practical teaching course about sedation based on simulation can improve the sedation's quality and the patients´ security.
Ethics approval(s)Ethics committee at Catholic University of Chile (Pontificia Universidad Catolica de Chile), 06/08/2013
Health condition(s) or problem(s) studiedSedation
InterventionA 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 typeBehavioural
Primary outcome measure1. 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 measuresSerious 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 study start date05/04/2013
Completion date12/10/2015

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participants10 participants
Key inclusion criteria1. Medical doctors who perform endoscopic procedures
2. Aged 25 to 65 years
3. Agreed to participate in the simulation sessions
Key exclusion criteriaParticipants that don't fulfill the inclusion criteria
Date of first enrolment05/04/2013
Date of final enrolment12/04/2015

Locations

Countries of recruitment

  • Chile

Study participating centre

Catholic University of Chile (Pontificia Universidad Catolica de Chile)
Christus Clinical Hospital
Marcoleta 367
Santiago
8330024
Chile

Sponsor information

Catholic University of Chile (Pontificia Universidad Catolica de Chile)
University/education

Marcoleta 367
Santiago
8330024
Chile

ROR logo "ROR" https://ror.org/04teye511

Funders

Funder type

Government

Comisión Nacional de Investigación Científica y Tecnológica
Government organisation / National government
Alternative name(s)
National Commission for Scientific and Technological Research, CONICYT
Location
Chile

Results and Publications

Intention to publish date31/12/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planDuring the present year I will submit the original paper to one journal dedicated preferentially to endoscopic procedures.
IPD sharing plan