NCT02563912

Brief Summary

Dosage errors are common in the stressful situation of a pediatric resuscitation. In addition to that, studies have reported that delays to provide medication is associated to worst survival rate for very sick children. To minimize delays and error, the investigators recently published a resuscitation handbook who provides drug dosages for each weight for children thus eliminating the need for dosage calculation. Once the weight of the patient is known, the physicians only have to open the book at the page corresponding to the weight and all the medications with their calculated dosage are provided. The primary goal of this study is to evaluate the number of dosage error during simulated pediatric resuscitation comparing residents using the handbook vs. utilisation of a chart providing non-calculated dosage. This will be an experimental crossover trial among 40 residents performing four simulated case-scenarios in a high-fidelity simulation lab.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

September 27, 2015

Last Update Submit

April 5, 2016

Conditions

Keywords

Childrenresuscitationsimulationmedication error

Outcome Measures

Primary Outcomes (1)

  • Having at least one dosage error in any of the medications during the case for a participant

    Difference of \> 10% of the recommended drug dosage for any of the medication provided during the simulated case scenario. To be perfect, there must be no error among all drugs provided.

    During the simulation (10 minutes)

Secondary Outcomes (2)

  • Dosage error in any for all individual medications during the case for a participant

    During the simulation (10 minutes)

  • Time for first drug prescription for each case per participant

    During the simulation (10 minutes)

Study Arms (2)

Handbook

EXPERIMENTAL

Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.

Other: Handbook

Medication chart

ACTIVE COMPARATOR

Medication chart who provides drug dosages for each weight for children. For example,it is written that the dosage of epinephrin is 0.01 mg/kg.

Other: Medication chart

Interventions

Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.

Handbook

Medication chart who provides drug dosages for each weight for children. For example,it is written that the dosage of epinephrin is 0.01 mg/kg.

Medication chart

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents doing a rotation in pediatrics emergency medicine

You may not qualify if:

  • Resident who participated in a previous month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, FRCPC

Study Record Dates

First Submitted

September 27, 2015

First Posted

September 30, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations