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Pediatric Intubation During Emergency Conditions

Primary Purpose

Endotracheal Intubation, Pediatric, Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Macintosh laryngoscope
Miller laryngoscope
McGrath MAC EMS
GlideScope
Sponsored by
Lazarski University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endotracheal Intubation focused on measuring difficult airway, endotracheal intubation, chest compression, physician

Eligibility Criteria

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

Inclusion Criteria:

  • paramedics
  • give voluntary consent to participate in the study
  • none experience in videolaryngoscopy
  • less than 1 year experience in medicine

Exclusion Criteria:

  • not meet the above criteria
  • wrist or low back diseases

Sites / Locations

  • Lazarsku University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Normal airway scenario

Tongue edema scenario

Spinal immobilization with normal airway scenario

Spinal immobilization with tongue edema scenario

Arm Description

intubation in normal airway scenario

intubation in the tongue edema scenario. Tongue edema was obtain using simulator indicators

intubation in spinal immobilization with normal airway scenario

endotracheal intubation with immobilized cervical spine and tongue edema scenario

Outcomes

Primary Outcome Measures

Intubation time
time in seconds required for a successful intubation attempt

Secondary Outcome Measures

Success of intubation
If the oesopharyngeal tube was incorrectly placed or intubation lasted longer than 60 seconds, the airway-management attempt was defined as a failure.
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading, scale developed by Cormack and Lehane, based on four degrees of visibility of the glottis.
POGO score - percentage of glottic opening
self-reported percentage the vocal cord visualization. A 100% POGO score is a full view of the glottis from the anterior commissure to the interarytenoid notch. A POGO score of 0 means that even the interarytenoid notch is not seen.
Preferred ETI device
participants were asked which method of ETI they would prefer in a real-life resuscitation.
Ease of use
self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy

Full Information

First Posted
June 29, 2018
Last Updated
July 29, 2019
Sponsor
Lazarski University
Collaborators
Wroclaw Medical University, The Cleveland Clinic, Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03602183
Brief Title
Pediatric Intubation During Emergency Conditions
Official Title
A Comparison of Direct vs. Video-laryngoscopes for Different Emergency Pediatric Airway Scenarios
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 27, 2018 (Actual)
Primary Completion Date
July 20, 2019 (Actual)
Study Completion Date
July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lazarski University
Collaborators
Wroclaw Medical University, The Cleveland Clinic, Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The effectiveness of endotracheal intubation in pre-hospital conditions is insufficient - especially in the context of pediatric patients. Anatomical differences in pediatric patients compared to adults: a relative larger tongue, a larger and more flabby epiglottis - located more cephalously - that make intubation is more difficult than for adults. Also, higher oxygen metabolism requires the immediate response of medical personnel to children in case of need to protect the airways and support breath.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotracheal Intubation, Pediatric, Cardiac Arrest, Injuries
Keywords
difficult airway, endotracheal intubation, chest compression, physician

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Normal airway scenario
Arm Type
Experimental
Arm Description
intubation in normal airway scenario
Arm Title
Tongue edema scenario
Arm Type
Experimental
Arm Description
intubation in the tongue edema scenario. Tongue edema was obtain using simulator indicators
Arm Title
Spinal immobilization with normal airway scenario
Arm Type
Experimental
Arm Description
intubation in spinal immobilization with normal airway scenario
Arm Title
Spinal immobilization with tongue edema scenario
Arm Type
Experimental
Arm Description
endotracheal intubation with immobilized cervical spine and tongue edema scenario
Intervention Type
Device
Intervention Name(s)
Macintosh laryngoscope
Other Intervention Name(s)
MAC
Intervention Description
intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
Intervention Type
Device
Intervention Name(s)
Miller laryngoscope
Other Intervention Name(s)
MIL
Intervention Description
intubation will be performed using Miller laryngoscope
Intervention Type
Device
Intervention Name(s)
McGrath MAC EMS
Other Intervention Name(s)
McGrath
Intervention Description
intubation will be performed using McGrath MAC EMS video - laryngoscope
Intervention Type
Device
Intervention Name(s)
GlideScope
Other Intervention Name(s)
GLS
Intervention Description
intubation will be performed using GlideScope video - laryngoscope
Primary Outcome Measure Information:
Title
Intubation time
Description
time in seconds required for a successful intubation attempt
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Success of intubation
Description
If the oesopharyngeal tube was incorrectly placed or intubation lasted longer than 60 seconds, the airway-management attempt was defined as a failure.
Time Frame
1 day
Title
Cormack-Lehane grading
Description
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading, scale developed by Cormack and Lehane, based on four degrees of visibility of the glottis.
Time Frame
1 day
Title
POGO score - percentage of glottic opening
Description
self-reported percentage the vocal cord visualization. A 100% POGO score is a full view of the glottis from the anterior commissure to the interarytenoid notch. A POGO score of 0 means that even the interarytenoid notch is not seen.
Time Frame
1 day
Title
Preferred ETI device
Description
participants were asked which method of ETI they would prefer in a real-life resuscitation.
Time Frame
1 day
Title
Ease of use
Description
self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: paramedics give voluntary consent to participate in the study none experience in videolaryngoscopy less than 1 year experience in medicine Exclusion Criteria: not meet the above criteria wrist or low back diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak, PhD
Organizational Affiliation
Lazarski University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lazarsku University
City
Warsaw
State/Province
Masovian
ZIP/Postal Code
02-662
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
data will be available from the main investigator
Citations:
PubMed Identifier
27228145
Citation
Szarpak L, Karczewska K, Czyzewski L, Truszewski Z, Kurowski A. Airtraq Laryngoscope Versus the Conventional Macintosh Laryngoscope During Pediatric Intubation Performed by Nurses: A Randomized Crossover Manikin Study With Three Airway Scenarios. Pediatr Emerg Care. 2017 Nov;33(11):735-739. doi: 10.1097/PEC.0000000000000741.
Results Reference
background
PubMed Identifier
28429117
Citation
Madziala M, Smereka J, Dabrowski M, Leung S, Ruetzler K, Szarpak L. A comparison of McGrath MAC(R) and standard direct laryngoscopy in simulated immobilized cervical spine pediatric intubation: a manikin study. Eur J Pediatr. 2017 Jun;176(6):779-786. doi: 10.1007/s00431-017-2909-9. Epub 2017 Apr 21.
Results Reference
background
PubMed Identifier
25979300
Citation
Szarpak L, Kurowski A, Czyzewski L, Rodriguez-Nunez A. Video rigid flexing laryngoscope (RIFL) vs Miller laryngoscope for tracheal intubation during pediatric resuscitation by paramedics: a simulation study. Am J Emerg Med. 2015 Aug;33(8):1019-24. doi: 10.1016/j.ajem.2015.04.054. Epub 2015 Apr 30.
Results Reference
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Pediatric Intubation During Emergency Conditions

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