Pediatric Intubation During Emergency Conditions

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602183
• Other study ID #: ETI_2018_PALS
• Status: Completed
• Phase: N/A
• Start date: July 27, 2018
• Est. completion date: July 20, 2019

Study information

• Verified date: July 2019
• Source: Lazarski University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 20, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Emergencies
• Endotracheal Intubation
• Heart Arrest
• Injuries
• Pediatric

Intervention

Device:
• Macintosh laryngoscope
intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
• Miller laryngoscope
intubation will be performed using Miller laryngoscope
• McGrath MAC EMS
intubation will be performed using McGrath MAC EMS video - laryngoscope
• GlideScope
intubation will be performed using GlideScope video - laryngoscope

Locations

Country	Name	City	State
Poland	Lazarsku University	Warsaw	Masovian

Sponsors (4)

Lead Sponsor	Collaborator
Lazarski University	Medical University of Vienna, The Cleveland Clinic, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Madziala M, Smereka J, Dabrowski M, Leung S, Ruetzler K, Szarpak L. A comparison of McGrath MAC® 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. — View 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. — View Citation

Szarpak L, Kurowski A, Czyzewski L, Rodríguez-Núñez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation time	time in seconds required for a successful intubation attempt	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	Preferred ETI device	participants were asked which method of ETI they would prefer in a real-life resuscitation.	1 day
Secondary	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	1 day