VL vs DL in Inexperienced Users: a Pediatric Manikin Study

Comparison of Miller and Macintosh Laryngoscopes, CMAC and Glidescope Videolaryngoscopes in Inexperienced Users: a Pediatric Manikin Study

This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance of users. This will involve the use of an intubating pediatric manikin to assess various aspects of endotracheal intubation by experienced and inexperienced users.

Study Overview

• Status: Completed
• Conditions: Videolaryngoscopes (VL); Direct Laryngoscopy (DL); Inexperienced Users
• Intervention / Treatment: Device: Miller; Device: Macintosh; Device: C-MAC; Device: GlideScope

Detailed Description

The commonly used method for endotracheal intubation in children is direct laryngoscopy using a Miller or Macintosh blade. Videolaryngoscopy is a widely accepted pediatric airway management. Videolaryngoscopes (VL) provide an indirect view of glottis without the need to align the oral, pharyngeal, and glottis structures. Some types of VLs provide also direct view of glottis with indirect view. Videolaryngoscopes can be used as a teaching tool for learners as they can visualize all the anatomical structures of larynx at the same time with the performer. VLs may facilitate the learning of endotracheal intubation in inexperienced users in the pediatric population. There are limited data on the use of videolaryngoscopes by anesthesia providers and medical personnel who are inexperienced in the use of videolaryngoscopes.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Faculty pediatric anesthesiologists
• CRNAs
• Trainees (SRNAs, residents, fellows, and medical students)
• Nurses from NCH

Exclusion Criteria:

• If subjects are unwilling to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inexperienced users; Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.	Device: Miller; Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope; Device: Macintosh; Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope; Device: C-MAC; Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope; Device: GlideScope; Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope
Experimental: Experienced users; Experienced users will include faculty pediatric anesthesiologists CRNAs.	Device: Miller; Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope; Device: Macintosh; Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope; Device: C-MAC; Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope; Device: GlideScope; Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Endotracheal Intubation	The amount of time it took to successfully intubate the manikin using each device.	the same day (within seconds to minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Intubation Within 120 Seconds	The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.	2 minutes

Collaborators and Investigators

• Sponsor: Joseph D. Tobias
• Investigators: Principal Investigator: Joseph Tobias, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB16-00549