NCT03071367

Brief Summary

Multiple studies have shown clinical simulation benefits over classical learning method. Research on simulation of airway management has focused on endotracheal intubation training, while research on ventilation via facemask is scant. The investigators compared both learning methods regarding the acquirement of basic skills for airway management by medical students. Students in the clinical simulation group received a 3-hour training on airway management on the first day of their 28-day anesthesia rotation, while classical learning did not. On the last day of rotation, participants were evaluated based on a validated instrument of scores. Primary outcome was airway management scores. Secondary outcomes were rate of success of intubation and incidence of complications.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

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

August 20, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

March 1, 2017

Last Update Submit

March 6, 2017

Conditions

Educational Activities

Keywords

Airway ManagementMedical studentsIntratracheal intubationEducational Technology

Outcome Measures

Primary Outcomes (1)

  • Airway management score

    28 days

Secondary Outcomes (2)

  • Successful intubation rate

    28 days

  • Incidence of complications

    28 days

Study Arms (2)

Clinical Simulation

EXPERIMENTAL
Other: Clinical Simulation

Classical Learning

NO INTERVENTION

Interventions

Clinical SimulationOTHER
Clinical Simulation

Eligibility Criteria

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

You may qualify if:

  • Last year medical students at Universidad de los Andes
  • Over 18 year old

You may not qualify if:

  • Previous elective anesthesia rotation
  • Motor deficit affecting the upper limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 6, 2017

Study Start

August 20, 2012

Primary Completion

February 20, 2014

Study Completion

June 20, 2014

Last Updated

March 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share