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Videolaryngoscopy During Child Intubation

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
MAC
Coopdech
CoPilot
Intubrite
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 - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Give voluntary consent to participate in the study
  • minimum 1 year of work experience in health care

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 using each device

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
NCT02289664
Brief Title
Videolaryngoscopy During Child Intubation
Official Title
A Comparison of Coopdech, Intubrite, and CoPilot Video-laryngoscopes With Macintosh Laryngoscope for Tracheal Intubation in Pediatric Patients During Resuscitation. Randomized Crossover Manikin 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
We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of three video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with and without chest compressions using an child manikin.

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
80 (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)
MAC
Other Intervention Name(s)
Macintosh Laryngoscope
Intervention Description
Direct-Laryngoscopy
Intervention Type
Device
Intervention Name(s)
Coopdech
Other Intervention Name(s)
Coopdech Video Lartyngoscope Portable VLP-100
Intervention Description
Video-Laryngoscopy -1
Intervention Type
Device
Intervention Name(s)
CoPilot
Other Intervention Name(s)
CoPilot Video Laryngoscope
Intervention Description
Video-Laryngoscopy -2
Intervention Type
Device
Intervention Name(s)
Intubrite
Other Intervention Name(s)
Intubrite Video Laryngoscope System VLS 6600
Intervention Description
Video-Laryngoscopy -3
Primary Outcome Measure Information:
Title
Success of intubation
Description
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants using each device
Time Frame
1 MONTH
Secondary Outcome Measure Information:
Title
Intubation time
Description
time in seconds required for a successful intubation attempt
Time Frame
1 MONTH
Title
POGO score
Description
self-reported percentage of glottis opening (POGO) score
Time Frame
1 mONTH
Title
Cormack-Lehane grading
Description
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Time Frame
1 MONTH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 health care 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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Videolaryngoscopy During Child Intubation

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