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

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1 month

First QC Date

November 7, 2014

Last Update Submit

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

EXPERIMENTAL

The control scenario, where neither chest compression nor cervical stabilization was applied during intubation.

Device: Macintosh LaryngoscopeDevice: TruView PCD Video laryngoscope

Scenario B

EXPERIMENTAL

The 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.

Device: Macintosh LaryngoscopeDevice: TruView PCD Video laryngoscope

Scenario C

EXPERIMENTAL

The 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.

Device: Macintosh LaryngoscopeDevice: TruView PCD Video laryngoscope

Interventions

Direct-Laryngoscopy

Scenario AScenario BScenario C

Video-Laryngoscopy

Scenario AScenario BScenario C

Eligibility Criteria

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

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

Location

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.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

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

Locations