Simulation can improve patients' security in endoscopic procedures

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN11222101
• Date of registration: 02/02/2016
• Prospective Registration: No
• Primary sponsor: Catholic University of Chile (Pontificia Universidad Catolica de Chile)
• Public title: Simulation can improve patients' security in endoscopic procedures
• Scientific title: The use of simulation to improve patients' security under sedation in endoscopic procedures
• Date of first enrolment: 05/04/2013
• Target sample size: 10
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11222101
• Study type: Interventional
• Study design: Prospective interventional single-centre non randomised clinical trial (Prevention)

Countries of recruitment

Chile

Contacts

• Name: Alejandro Delfino

Key inclusion & exclusion criteria

Inclusion criteria: 1. Medical doctors who perform endoscopic procedures
2. Aged 25 to 65 years
3. Agreed to participate in the simulation sessions
Exclusion criteria: Participants that don't fulfill the inclusion criteria

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Sedation
Surgery

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Comisión Nacional de Investigación Científica y Tecnológica