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Pediatric Endotracheal Intubation (EMS)

Primary Purpose

Cardiac Arrest, Intubation, Endotracheal

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
McGrath
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

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 Education

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
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

Full Information

First Posted
November 11, 2014
Last Updated
December 4, 2014
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02291653
Brief Title
Pediatric Endotracheal Intubation
Acronym
EMS
Official Title
Comparing the Novel McGrath MAC EMS Videolaryngoscope With Conventional Direct Laryngoscopy During Child Resuscitation: a Randomized Crossover Mannequin Study of Paramedic Students
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

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
No

5. Study Description

Brief Summary
We hypothesized that the McGrath MAC EMS is beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of the McGrath MAC EMS 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, Intubation, Endotracheal

7. Study Design

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

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)
McGrath
Other Intervention Name(s)
McGrath MAC EMS
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
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
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

12. IPD Sharing Statement

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Pediatric Endotracheal Intubation

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