Pediatric Intubation
ETICPR
Comparison of the TruView PCD Video Laryngoscope and Macintosh Laryngoscope for Pediatric Tracheal Intubation by Novice Paramedics: A Randomized Crossover Simulation Trial.
1 other identifier
interventional
120
1 country
1
Brief Summary
The aim of the study was to compare time and success rates of TruView PCD video laryngoscope and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios in a standardized manikin model.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Shorter than P25 for not_applicable
1 active site
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
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 7, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 26, 2015
January 1, 2015
1 month
November 7, 2014
January 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Time to intubation
the time to intubation, defined as the time from insertion of the laryngoscope blade between the teeth to the first manual ventilation of the mannequin's lungs
1 day
Secondary Outcomes (4)
Success of intubation
1 day
Cormack-Lehan scale
1 day
Dental compression
1day
Ease of intubation (VAS)
1 day
Study Arms (3)
Scenario A
EXPERIMENTALThe control scenario, where neither chest compression nor cervical stabilization was applied during intubation.
Scenario B
EXPERIMENTALThe chest compression scenario, where continuous chest compression was applied using chest compression system LUCAS-2 (Physio-Control, Redmond, WA, USA). Chest compression was provided at a rate of 100 min-1 to a depth of 5-6 cm during all intubation procedures.
Scenario C
EXPERIMENTALThe chest compression with cervical stabilization scenario, where both chest compression using Lucas-2 and cervical stabilization were applied. A correctly fitting standard cervical immobilization collar (StifNeck Select, Laerdal, Stavanger, Norway) was applied to the manikin's neck to prevent movement of the cervical spine.
Interventions
Eligibility Criteria
You may qualify if:
- give voluntary consent to participate in the study
- inexperienced in pediatric intubation paramedics
You may not qualify if:
- not meet the above criteria
- participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Institute of Rescue Research and Education
Warsaw, Masovie, 03-122, Poland
Related Publications (1)
Szarpak L, Czyzewski L, Kurowski A, Truszewski Z. Comparison of the TruView PCD video laryngoscope and macintosh laryngoscope for pediatric tracheal intubation by novice paramedics: a randomized crossover simulation trial. Eur J Pediatr. 2015 Oct;174(10):1325-32. doi: 10.1007/s00431-015-2538-0. Epub 2015 Apr 18.
PMID: 25894914DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- Lukasz Szarpak
Study Record Dates
First Submitted
November 7, 2014
First Posted
November 13, 2014
Study Start
November 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 26, 2015
Record last verified: 2015-01