ClinicalTrials.Veeva

Menu

Simulation-based Curriculum to Enhance Culture of Safety in Operating Rooms (PROPECS)

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Surgery

Treatments

Other: Simulation - based curriculum

Study type

Observational

Funder types

Other

Identifiers

NCT02152436
2013-32

Details and patient eligibility

About

Communication in the operating room (OR) is a key factor to prevent deleterious events for the patient. French national health authority made the implementation of safety checklist mandatory in operating rooms. The goal of this checklist is to improve teamwork and share key elements for better patient outcomes. Observational studies in the OR showed low compliance to this checklist, either on the way it is used or on the information implemented.

The primary objective of this project is to assess the efficacy of a simulation-based curriculum involving OR medical and non-medical personnel in order to improve communication in the OR.

Full description

Operating theater is a complex system where efficient communication is critical to patient safety. Patient safety check-list are used worldwide as a way to improve communication and teamwork in the operating room in order to decrease perioperative morbidity and mortality. Previous studies have shown that communication failure in the OR may be associated with adverse events. The improvement of safety culture (including communication and team work) may be obtained by simulation based training.

The primary objective of this before-after study is to assess the efficacy of a simulation-based curriculum involving OR medical and non medical personnel in order to improve communication in the OR.

In brief, in a first period, an audit to assess communication efficacy and teamwork will be realized during 125 surgical procedures. Communication failures and consequences will be recorded using a standardized form filled by trained personnel. In a second phase, all the OR personnel (surgeon, anesthesiologist, nurses) will be invited to participate to a special training on communication and teamwork. This curriculum will include formal presentations and also simulation-based training. Scenarios are built to improve the ability to communicate in specific situations (fire in the OR, haemorrhage, wrong side, anaphylaxis).

In a third phase, an audit on communication and teamwork, similar to the first phase will be realized. The primary endpoint is the frequency of surgical interventions having at least one communication failure with a consequence. The investigators expect a significant decrease in the rate of communication failures between phase 1 and 3. A fourth phase will consist in a last audit two years after phase 1 to evaluate long-term effect of this curriculum.

Enrollment

259 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All surgical interventions occuring in Grenoble University Hospital, North site, between November and January

Exclusion criteria

  • Interventions supposed to last more than 4 hours
  • Interventions in situations of vital emergencies

Trial design

259 participants in 2 patient groups

Before simulation-based curriculum
Description:
125 surgical interventions will be observed and outcomes will be measured before simulation-based curriculum
After simulation-based curriculum
Description:
125 surgical interventions will be observed and outcomes will be measured after simulation-based curriculum
Treatment:
Other: Simulation - based curriculum

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems