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Pediatric Difficult Intubation (3V-L DL)

Primary Purpose

Intubation, Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Vividtrac
MIL
Sponsored by
International Institute of Rescue Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intubation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Give voluntary consent to participate in the study
  • Paramedic student

Exclusion Criteria:

  • Not meet the above criteria
  • Wrist or Low back diseases

Sites / Locations

  • International Institute of Rescue Research and EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Endotracheal intubation without chest compressions

Endotracheal intubation with uninterrupted chest compressions

Arm Description

Endotracheal intubation of mannikin during resuscitation without chest compressions.

Endotracheal intubation of mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).

Outcomes

Primary Outcome Measures

Time to intubation
time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure

Secondary Outcome Measures

Success of intubation
effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations. Visual Analog scale (VAS) score
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

Full Information

First Posted
November 18, 2014
Last Updated
November 18, 2014
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02295670
Brief Title
Pediatric Difficult Intubation
Acronym
3V-L DL
Official Title
Can the Vividtrac Laryngoscope Rival the Miller Laryngoscope for Child Tracheal Intubation During Chest Compression in a Manikin? A Randomized Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Institute of Rescue Research and Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR). These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. The aim of the study was to compare time and success rates of the Vividtrac video-laryngoscope and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation, Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endotracheal intubation without chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation of mannikin during resuscitation without chest compressions.
Arm Title
Endotracheal intubation with uninterrupted chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation of mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).
Intervention Type
Device
Intervention Name(s)
Vividtrac
Intervention Description
video-laryngoscopy
Intervention Type
Device
Intervention Name(s)
MIL
Other Intervention Name(s)
miller larygoscopy
Intervention Description
direct-laryngoscopy
Primary Outcome Measure Information:
Title
Time to intubation
Description
time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Success of intubation
Description
effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations. Visual Analog scale (VAS) score
Time Frame
1 day
Title
Cormack-Lehane grading
Description
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Give voluntary consent to participate in the study Paramedic student Exclusion Criteria: Not meet the above criteria Wrist or Low back diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lukasz Szarpak
Phone
+48500186225
Email
lukasz.szarpak@gmail.com
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovie
ZIP/Postal Code
03-122
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Phone
+48500186225
Email
lukasz.szarpak@gmail.com

12. IPD Sharing Statement

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Pediatric Difficult Intubation

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