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ETICPR: Pediatric Intubation

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Completed
CT.gov ID
NCT02289872
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
30
Duration (Days)
121.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Macintosh Laryngoscope
  • Device: TruView PCD Video laryngoscope
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the TruView PCD Video Laryngoscope and Macintosh Laryngoscope for Pediatric Tracheal Intubation by Novice Paramedics: A Randomized Crossover Simulation Trial.
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Scenario A

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

Device: Macintosh Laryngoscope
Direct-Laryngoscopy

Device: TruView PCD Video laryngoscope
Video-Laryngoscopy
Experimental: Scenario B

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 Laryngoscope
Direct-Laryngoscopy

Device: TruView PCD Video laryngoscope
Video-Laryngoscopy
Experimental: Scenario C

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 Laryngoscope
Direct-Laryngoscopy

Device: TruView PCD Video laryngoscope
Video-Laryngoscopy

Outcome Measures

Primary Outcome Measures

  1. Time to intubation [1 day]

    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

Secondary Outcome Measures

  1. Success of intubation [1 day]

    success of the intubation attempt (i.e. tracheal or oesophageal placement of the tube) with was recorded when the success of the ventilation attempt was seen by the manikin's ventilation indicators.

  2. Cormack-Lehan scale [1 day]

    self reported Cormack-Lehan scale during intubation

  3. Dental compression [1day]

    dental compression, with was assessed using a visual scale grading the pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3).

  4. Ease of intubation (VAS) [1 day]

    To access subjective opinion about the difficulty of the each intubation method, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • give voluntary consent to participate in the study

  • inexperienced in pediatric intubation paramedics

Exclusion Criteria:

  • not meet the above criteria

  • participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience

Contacts and Locations

Locations

Site City State Country Postal Code
1 International Institute of Rescue Research and Education Warsaw Masovie Poland 03-122

Sponsors and Collaborators

  • International Institute of Rescue Research and Education

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT02289872
Other Study ID Numbers:
  • TruView/01
First Posted:
Nov 13, 2014
Last Update Posted:
Jan 26, 2015
Last Verified:
Jan 1, 2015
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of Jan 26, 2015