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

NCT ID: NCT01023568

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-05-31

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.

Conditions

Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Macintosh blade

Intubation with Macintosh blade laryngoscope

Group Type: ACTIVE_COMPARATOR

Macintosh blade

Intervention Type: DEVICE

Intubation with Macintosh blade laryngoscope

Glidescope

Intubation with Glidescope laryngoscope

Group Type: ACTIVE_COMPARATOR

Glidescope

Intervention Type: DEVICE

Intubation with Glidescope laryngoscope.

Truview PCD

Intubation with the Truview PCD laryngoscope

Group Type: ACTIVE_COMPARATOR

Truview PCD

Intervention Type: DEVICE

Intubation with Truview PCD laryngoscope.

Interventions

Macintosh blade

Intubation with Macintosh blade laryngoscope

Intervention Type: DEVICE

Glidescope

Intubation with Glidescope laryngoscope.

Intervention Type: DEVICE

Truview PCD

Intubation with Truview PCD laryngoscope.

Intervention Type: DEVICE

Eligibility Criteria

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

• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Niezgoda, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

09-902

Identifier Type: -

Identifier Source: org_study_id