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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02572427
Other study ID # 202043
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date November 2014

Study information

Verified date July 2016
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall goal of this study was to create a simulation environment with repeated practice for residents and intense, immediate feedback. Repeated simulations for neonatal resuscitation when coupled with clinical experience have been shown to improve resident confidence.The investigators sought to determine if resident exposure to individual training and video laryngoscopy using the C-MAC video laryngoscope would improve cognitive skills and decrease intubation times in a neonatal manikin. The primary outcome was time to intubation after one year. The secondary outcome was the ability to retain cognitive instruction related to intubation


Description:

Objective: Tracheal intubation of infants and children is a critical lifesaving skill, but many upper level pediatric residents are unable to successfully intubate neonates or pediatric patients in a timely manner. Simulation has been shown to be effective in teaching procedural skills, but it is not known if improvements in intubation skills can persist. The investigators sought to determine if video laryngoscopy could be used to enhance resident intubation skills that would be retained for one year. Methods: There were 67 Pediatric and Internal Medicine/Pediatric residents, levels 1-4, who completed the study and were randomized by month of service into non-intervention (NI, n= 36) and intervention (IN, n=31) groups. IN residents observed the intubation portion of the Neonatal Resuscitation Program (NRP) training video and received cognitive instruction and 30 minutes of hands on instruction using a video laryngoscope. At the study's conclusion, 12 months after enrollment, residents completed a survey of intubations of live patients over the past year, a cognitive assessment of intubation, and were timed on intubating a manikin. Results were analyzed by Student's T-Test.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion criteria: - Pediatric residents Exclusion criteria: - Residents from other departments - Neonatology fellows - Medical students - Medical school Faculty

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education for intubation skills
Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab.
No added education for intubation skills
Routine training in neonatal resuscitation but no added experience in simulation lab.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Outcome

Type Measure Description Time frame Safety issue
Primary Skill in Intubating Neonatal Manikin Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab Up to two minutes
Secondary Knowledge Concerning Intubation of Neonates Score on cognitive test on intubation of neonates.Scores ranged on scale from 0 to 21 , with higher score indicating greater knowledge (better outcome). 30 minutes
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