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Effectiveness of Child Intubation

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Intubrite
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 Cardiac Arrest focused on measuring intubation

Eligibility Criteria

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

Inclusion Criteria:

  • Give voluntary consent to participate in the study
  • minimum 1 year of work experience in emergency medicine
  • experienced emergency medical personnel (physicians, nurses, paramedics)

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

Intubation without chest compressions

Intubation with uninterrupted chest compressions

Arm Description

Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.

Endotracheal intubation of pediatric 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

Success of intubation
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants

Secondary Outcome Measures

Intubation time
time in seconds required for a successful intubation attempt
POGO score
self-reported percentage of glottis opening (POGO) score
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

Full Information

First Posted
November 10, 2014
Last Updated
November 12, 2014
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02289638
Brief Title
Effectiveness of Child Intubation
Official Title
First Comparison of the /Intubrite VideoLaryngoscope System Versus the Miller Laryngoscope for Intubations by Non-anaesthetists: a Manikin Study.
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
November 2014 (Anticipated)
Study Completion Date
November 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
We hypothesized that the Intubrite Video Laryngoscope System VLS 6600 is beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of the Intubrite and MIL laryngoscopes in child resuscitation with and without CC.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intubation without chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.
Arm Title
Intubation with uninterrupted chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation of pediatric 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)
Intubrite
Other Intervention Name(s)
Intubrite Video Laryngoscope System VLS 6600
Intervention Description
Video-Laryngoscopy
Intervention Type
Device
Intervention Name(s)
MIL
Other Intervention Name(s)
Miller Laryngoscope
Intervention Description
Direct-Laryngoscopy
Primary Outcome Measure Information:
Title
Success of intubation
Description
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Intubation time
Description
time in seconds required for a successful intubation attempt
Time Frame
1 day
Title
POGO score
Description
self-reported percentage of glottis opening (POGO) 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 minimum 1 year of work experience in emergency medicine experienced emergency medical personnel (physicians, nurses, paramedics) 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
Andrzej Kurowski
Phone
+48500186225
Email
andrzejkurowski987@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Organizational Affiliation
Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovia
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
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
First Name & Middle Initial & Last Name & Degree
Andrzej Kurowski
First Name & Middle Initial & Last Name & Degree
Lukasz Czyżewski

12. IPD Sharing Statement

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Effectiveness of Child Intubation

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