Clinical trial NCT01023568: Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients
Official title: Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intubation
Keywords: intubation
pediatric
videolaryngoscope devices
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 134
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Time to Successfully Intubate Patient.
timeFrame: from start of intubation to successfully intubated up to 5 minutes
Secondary outcomes:
measure: Mean Hemodynamic Response: Mean Arterial Blood Pressure
timeFrame: measured at 1 minute interval at induction time and from intubation for 10 minutes
measure: Cormack-Lehane Grade
timeFrame: immediately after intubation
measure: Mean Hemodynamic Response: Heart Rate
timeFrame: measured at 1 minute interval at induction time and from intubation for 10 minutes.
measure: Number of Participants Who Experienced Desaturation
timeFrame: measured at 1 minute interval at induction time and from intubation for 10 minutes.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Julie Niezgoda, MD
role: PRINCIPAL_INVESTIGATOR
References: