Pediatric Intubation During Emergency Conditions

NCT ID: NCT03602183

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-27

Study Completion Date

2019-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Endotracheal Intubation Pediatric Cardiac Arrest Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal airway scenario

intubation in normal airway scenario

Group Type EXPERIMENTAL

Macintosh laryngoscope

Intervention Type DEVICE

intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope

Miller laryngoscope

Intervention Type DEVICE

intubation will be performed using Miller laryngoscope

McGrath MAC EMS

Intervention Type DEVICE

intubation will be performed using McGrath MAC EMS video - laryngoscope

GlideScope

Intervention Type DEVICE

intubation will be performed using GlideScope video - laryngoscope

Tongue edema scenario

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

Group Type EXPERIMENTAL

Macintosh laryngoscope

Intervention Type DEVICE

intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope

Miller laryngoscope

Intervention Type DEVICE

intubation will be performed using Miller laryngoscope

McGrath MAC EMS

Intervention Type DEVICE

intubation will be performed using McGrath MAC EMS video - laryngoscope

GlideScope

Intervention Type DEVICE

intubation will be performed using GlideScope video - laryngoscope

Spinal immobilization with normal airway scenario

intubation in spinal immobilization with normal airway scenario

Group Type EXPERIMENTAL

Macintosh laryngoscope

Intervention Type DEVICE

intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope

Miller laryngoscope

Intervention Type DEVICE

intubation will be performed using Miller laryngoscope

McGrath MAC EMS

Intervention Type DEVICE

intubation will be performed using McGrath MAC EMS video - laryngoscope

GlideScope

Intervention Type DEVICE

intubation will be performed using GlideScope video - laryngoscope

Spinal immobilization with tongue edema scenario

endotracheal intubation with immobilized cervical spine and tongue edema scenario

Group Type EXPERIMENTAL

Macintosh laryngoscope

Intervention Type DEVICE

intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope

Miller laryngoscope

Intervention Type DEVICE

intubation will be performed using Miller laryngoscope

McGrath MAC EMS

Intervention Type DEVICE

intubation will be performed using McGrath MAC EMS video - laryngoscope

GlideScope

Intervention Type DEVICE

intubation will be performed using GlideScope video - laryngoscope

Interventions

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Macintosh laryngoscope

intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope

Intervention Type DEVICE

Miller laryngoscope

intubation will be performed using Miller laryngoscope

Intervention Type DEVICE

McGrath MAC EMS

intubation will be performed using McGrath MAC EMS video - laryngoscope

Intervention Type DEVICE

GlideScope

intubation will be performed using GlideScope video - laryngoscope

Intervention Type DEVICE

Other Intervention Names

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MAC MIL McGrath GLS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Lazarski University

OTHER

Sponsor Role lead

Responsible Party

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Ɓukasz Szarpak

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lukasz Szarpak, PhD

Role: PRINCIPAL_INVESTIGATOR

Lazarski University

Locations

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Lazarsku University

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 27228145 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28429117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25979300 (View on PubMed)

Other Identifiers

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ETI_2018_PALS

Identifier Type: -

Identifier Source: org_study_id

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