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

NeuroTherapia, Inc.

Status: Terminated

Conditions: Intubation

Treatments: Device: Macintosh blade; Device: Glidescope; Device: Truview PCD

Study type: Interventional

Funder types: Other

Identifiers

NCT01023568

09-902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: Under 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 3 patient groups

Macintosh blade

Active Comparator group

Description:

Intubation with Macintosh blade laryngoscope

Treatment:

Device: Macintosh blade

Glidescope

Active Comparator group

Description:

Intubation with Glidescope laryngoscope

Treatment:

Device: Glidescope

Truview PCD

Active Comparator group

Description:

Intubation with the Truview PCD laryngoscope

Treatment:

Device: Truview PCD