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

Not Applicable

Terminated

• Conditions: Intubation
• Interventions: Device: Macintosh blade; Device: Glidescope; Device: Truview PCD

• Registration Number: NCT01023568
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2016-06-21
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-08
• Last Update Submitted: 2016-12-08
• Results First Posted: 2017-02-02
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macintosh blade	Macintosh blade	Intubation with Macintosh blade laryngoscope
Glidescope	Glidescope	Intubation with Glidescope laryngoscope
Truview PCD	Truview PCD	Intubation with the Truview PCD laryngoscope

Primary Outcome Measures

Name	Time	Method
Time to Successfully Intubate Patient.	from start of intubation to successfully intubated up to 5 minutes

Secondary Outcome Measures

Name	Time	Method
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
Number of Participants Who Experienced Desaturation	measured at 1 minute interval at induction time and from intubation for 10 minutes.	Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after
Mean Hemodynamic Response: Heart Rate	measured at 1 minute interval at induction time and from intubation for 10 minutes.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States