Pediatric Intubation During Emergency Conditions

NCT03602183 | Completed DMC

• 1 other identifier: ETI_2018_PALS
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Intubation; Pediatric; Cardiac Arrest; Injuries

Keywords

difficult airway; endotracheal intubation; chest compression; physician

Outcome Measures

Primary Outcomes (1)

• Intubation time

  time in seconds required for a successful intubation attempt

  1 day

Secondary Outcomes (5)

• Success of intubation

  1 day

• Cormack-Lehane grading

  1 day

• POGO score - percentage of glottic opening

  1 day

• Preferred ETI device

  1 day

• Ease of use

  1 day

Study Arms (4)

Normal airway scenario

EXPERIMENTAL

intubation in normal airway scenario

Device: Macintosh laryngoscope; Device: Miller laryngoscope; Device: McGrath MAC EMS; Device: GlideScope

Tongue edema scenario

EXPERIMENTAL

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

Device: Macintosh laryngoscope; Device: Miller laryngoscope; Device: McGrath MAC EMS; Device: GlideScope

Spinal immobilization with normal airway scenario

EXPERIMENTAL

intubation in spinal immobilization with normal airway scenario

Device: Macintosh laryngoscope; Device: Miller laryngoscope; Device: McGrath MAC EMS; Device: GlideScope

Spinal immobilization with tongue edema scenario

EXPERIMENTAL

endotracheal intubation with immobilized cervical spine and tongue edema scenario

Device: Macintosh laryngoscope; Device: Miller laryngoscope; Device: McGrath MAC EMS; Device: GlideScope

Interventions

Macintosh laryngoscope DEVICE

intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope

Also known as: MAC

Normal airway scenario; Spinal immobilization with normal airway scenario; Spinal immobilization with tongue edema scenario; Tongue edema scenario

Miller laryngoscope DEVICE

intubation will be performed using Miller laryngoscope

Also known as: MIL

Normal airway scenario; Spinal immobilization with normal airway scenario; Spinal immobilization with tongue edema scenario; Tongue edema scenario

McGrath MAC EMS DEVICE

intubation will be performed using McGrath MAC EMS video - laryngoscope

Also known as: McGrath

Normal airway scenario; Spinal immobilization with normal airway scenario; Spinal immobilization with tongue edema scenario; Tongue edema scenario

GlideScope DEVICE

intubation will be performed using GlideScope video - laryngoscope

Also known as: GLS

Normal airway scenario; Spinal immobilization with normal airway scenario; Spinal immobilization with tongue edema scenario; Tongue edema scenario

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lazarski University: lead
• Wroclaw Medical University: collaborator
• The Cleveland Clinic: collaborator
• Medical University of Vienna: collaborator

Study Sites (1)

Lazarsku University

Warsaw, Masovian Voivodeship, 02-662, Poland

Location

Related Publications (3)

• 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.

  PMID: 27228145 BACKGROUND

• 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.

  PMID: 28429117 BACKGROUND

• 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.

  PMID: 25979300 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Wounds and Injuries

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Lukasz Szarpak, PhD

  Lazarski University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 26, 2018
• Study Start: July 27, 2018
• Primary Completion: July 20, 2019
• Study Completion: July 20, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

PL (1)