Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients

The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope devices, Glidescope and Truview provide better laryngeal views in pediatric patients as measured by Cormack and ehane (C&L) (1 to 4, 4 the worst), without increasing the time taken to intubate (TTI), compared with direct laryngoscopy (DL).

The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke less hemodynamic response and fewer episodes of de-saturation in pediatric patients.

Study Overview

• Status: Terminated
• Conditions: Intubation
• Intervention / Treatment: Device: Macintosh blade; Device: Glidescope; Device: Truview PCD

Detailed Description

Advances in airway management have led to development on videolaryngoscopy devices including the Glidescope® (Verathon Inc, Bothwell, USA), the AWD® (Pentax Corporation, Tokio, Japan) and most recently the Truview PCD (Truphatek International Ltd, Netanya, Israel). The use of videolaryngoscopy devices in adults have demonstrated some advantages including, minimal trauma on the airway and better view of the glottis.

The Glidescope is designed with a 60º angle and a camera on the inferior aspect just at the inflection point. The view is obtained anteriorly and the camera is located remote from the glottis providing a good visual field. The video image is displayed on a Liquid Crystal Display (LCD), with electronic recording available. Despite a good experience using Glidescope in adults, few studies have been published in pediatric patients. Kim et al. in a randomized study comparing the use of Glidescope with direct laryngoscopy in children, demonstrated better or equal laryngoscopic view with longer time for intubation using the Glidescope.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status I-III
• elective general surgical procedures
• from 0-10 years-old

Exclusion Criteria:

• increase intracranial pressure
• history of severe gastrointestinal reflux
• sore throat
• upper respiratory airway infection
• known or suspected difficult airway or coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Macintosh blade; Intubation with Macintosh blade laryngoscope	Device: Macintosh blade; Intubation with Macintosh blade laryngoscope
Active Comparator: Glidescope; Intubation with Glidescope laryngoscope	Device: Glidescope; Intubation with Glidescope laryngoscope.
Active Comparator: Truview PCD; Intubation with the Truview PCD laryngoscope	Device: Truview PCD; Intubation with Truview PCD laryngoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Successfully Intubate Patient.	from start of intubation to successfully intubated up to 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Hemodynamic Response: Mean Arterial Blood Pressure		measured at 1 minute interval at induction time and from intubation for 10 minutes
Cormack-Lehane Grade		immediately after intubation
Mean Hemodynamic Response: Heart Rate		measured at 1 minute interval at induction time and from intubation for 10 minutes.
Number of Participants Who Experienced Desaturation	Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after	measured at 1 minute interval at induction time and from intubation for 10 minutes.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Julie Niezgoda, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 1, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: pediatric; intubation; videolaryngoscope devices
• Other Study ID Numbers: 09-902