NCT02431130

Brief Summary

The goal of this study is to examine whether low-fidelity instructor-driven simulation can provide effective teaching of anesthetists' non-technical skills in a developing world context. Human factors, such as communication, planning, and team working are considered nontechnical skills which contribute greatly to patient safety in "complex hazardous systems" such as aviation, nuclear power industry, and operating rooms. Simulation began in the aviation industry to train pilots in human factors. In the past two decades simulation has been valued in medical education as it allows the learner to rehearse skills in an environment that is similar to the workplace but without the threat of harm to patients. High Fidelity simulators involve computer driven interactive mannequins that recreate an authentic environment. This has been used successfully to teach anesthetists' non-technical skills (ANTS) such as: decision making, team working, task management, and situation awareness. Anesthetists' non-technical skills are particularly important in developing countries where the shortage of supplies, equipment, and qualified personnel can lead to a perilous working environment making team work and communication vital for patient safety. The costs of high fidelity simulation are prohibitive for many developing countries. This study seeks to examine whether low fidelity instructor driven simulation can provide an effective intervention to teach anesthetists' non-technical skills in Rwanda. If found to be effective, this method of training could be applied to other developing countries to improve non-technical skills for anesthesia providers with the goal of making surgery safer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

April 23, 2015

Last Update Submit

September 5, 2023

Conditions

Keywords

Training Program

Outcome Measures

Primary Outcomes (1)

  • Improvement in overall ANTS score after simulation training

    two weeks after training

Study Arms (2)

Low-fidelty instructor driven simulation training

EXPERIMENTAL

participants receive simulation training

Other: low-fidelity instructor driven simulation training

No simulation training

NO INTERVENTION

Interventions

Low-fidelty instructor driven simulation training

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • anesthesia providers (resident or technician) that provides anesthesia for caesarean section

You may not qualify if:

  • anesthesia providers that do not provide anesthesia for caesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Global Health Office of Anesthesia

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 30, 2015

Study Start

February 1, 2012

Primary Completion

January 1, 2013

Study Completion

September 1, 2014

Last Updated

September 7, 2023

Record last verified: 2023-09