Pediatric Intubation During Emergency Conditions

July 29, 2019 updated by: Łukasz Szarpak, Lazarski University

A Comparison of Direct vs. Video-laryngoscopes for Different Emergency Pediatric Airway Scenarios

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovian
      • Warsaw, Masovian, Poland, 02-662
        • Lazarsku University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal airway scenario
intubation in normal airway scenario
Device: Macintosh laryngoscope
intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
Other Names:
  • MAC
Device: Miller laryngoscope
intubation will be performed using Miller laryngoscope
Other Names:
  • MIL
Device: McGrath MAC EMS
intubation will be performed using McGrath MAC EMS video - laryngoscope
Other Names:
  • McGrath
Device: GlideScope
intubation will be performed using GlideScope video - laryngoscope
Other Names:
  • GLS
Experimental: Tongue edema scenario
intubation in the tongue edema scenario. Tongue edema was obtain using simulator indicators
Device: Macintosh laryngoscope
intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
Other Names:
  • MAC
Device: Miller laryngoscope
intubation will be performed using Miller laryngoscope
Other Names:
  • MIL
Device: McGrath MAC EMS
intubation will be performed using McGrath MAC EMS video - laryngoscope
Other Names:
  • McGrath
Device: GlideScope
intubation will be performed using GlideScope video - laryngoscope
Other Names:
  • GLS
Experimental: Spinal immobilization with normal airway scenario
intubation in spinal immobilization with normal airway scenario
Device: Macintosh laryngoscope
intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
Other Names:
  • MAC
Device: Miller laryngoscope
intubation will be performed using Miller laryngoscope
Other Names:
  • MIL
Device: McGrath MAC EMS
intubation will be performed using McGrath MAC EMS video - laryngoscope
Other Names:
  • McGrath
Device: GlideScope
intubation will be performed using GlideScope video - laryngoscope
Other Names:
  • GLS
Experimental: Spinal immobilization with tongue edema scenario
endotracheal intubation with immobilized cervical spine and tongue edema scenario
Device: Macintosh laryngoscope
intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
Other Names:
  • MAC
Device: Miller laryngoscope
intubation will be performed using Miller laryngoscope
Other Names:
  • MIL
Device: McGrath MAC EMS
intubation will be performed using McGrath MAC EMS video - laryngoscope
Other Names:
  • McGrath
Device: GlideScope
intubation will be performed using GlideScope video - laryngoscope
Other Names:
  • GLS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: 1 day
time in seconds required for a successful intubation attempt
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of use
Time Frame: 1 day
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
1 day
Success of intubation
Time Frame: 1 day
If the oesopharyngeal tube was incorrectly placed or intubation lasted longer than 60 seconds, the airway-management attempt was defined as a failure.
1 day
Cormack-Lehane grading
Time Frame: 1 day
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.
1 day
POGO score - percentage of glottic opening
Time Frame: 1 day
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.
1 day
Preferred ETI device
Time Frame: 1 day
participants were asked which method of ETI they would prefer in a real-life resuscitation.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lazarski University

Collaborators

Medical University of Vienna
The Cleveland Clinic
Wroclaw Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2018

Primary Completion (Actual)

July 20, 2019

Study Completion (Actual)

July 20, 2019

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETI_2018_PALS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data will be available from the main investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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