A Comparison Between Two Video Laryngoscopes,in Successfully Intubating Pediatric Mannequins w/wo Difficult Airways

NCT02198742 | Completed Phase 1

• 1 other identifier: H28224
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized crossover study where anesthesia practitioners will intubate three different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome anatomy) using three different intubation devices (the Miller blade, the Truview VL, the Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an immobile neck). The order of presentation will be randomized. As this is a cross over study, all subjects will complete all scenarios. There is no placebo group, and each subject wil be his or her own control.

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

• Time required for successful endotracheal intubation with the three devices.

  The devices to be compared include (1)the standard Miller blade, (2) the GlideScope Cobalt AVL and (3) the Truview PCD video-laryngoscopes. Successful intubation will be measured in the seconds from the time the recorder says "begin" until time of first positive pressure breath and confirmation endotracheal tube is in the trachea.

  Subjects complete study in 1 day

Secondary Outcomes (7)

• Time to visualize the larynx

  From time recorder says "begin" till subject rates best view up to 3minutes

• Time from visualization of larynx to tracheal intubation

  one day

• Number of attempts at tracheal intubation

  one day

• Number of failed attempts

  one day

• Amount of force on the maxilla

  one day

Study Arms (3)

Miller blade

ACTIVE COMPARATOR

Subjects must have \>500 intubations in order to participate in this study. There is no placebo group, and each subject wil be his or her own control.

Device: Miller blade

Truview PCD

ACTIVE COMPARATOR

Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable. There is no placebo group, and each subject wil be his or her own control.

Device: Truview PCD

Glidescope Cobolt

ACTIVE COMPARATOR

Subjects were required to watch a instructional video provided by the manufacterer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.

Device: Glidescope Cobolt

Interventions

Miller blade DEVICE

To participate in the study the subjects must have \>500 intubations with the miller blade.

Miller blade

Truview PCD DEVICE

Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable.

Also known as: Trueview PCD - Multichoice video laryngoscope system

Truview PCD

Glidescope Cobolt DEVICE

Subjects were required to watch a instructional video provided by the manufacturer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.

Glidescope Cobolt

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Anesthesia practitioners including anesthesia attendings, fellows, residents CAIII and CRNA's at Texas Children's Hospital Department of Anesthesiology with clinical experience of \>500 intubations with Miller blades.

You may not qualify if:

• Anesthesia practitioners with \<500 intubations with Miller blades.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children't Hospital

Houston, Texas, 77030, United States

Location

Study Officials

• Helena Karlberg, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Anesthesiologist

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: July 24, 2014
• Study Start: June 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 3, 2015

Record last verified: 2015-02

Locations

US (1)