Condition category
Surgery
Date applied
01/02/2016
Date assigned
02/02/2016
Last edited
02/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Catholic University of Chile (Pontificia Universidad Catolica de Chile)

Sponsor details

Marcoleta 367
Santiago
8330024
Chile

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes