Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- The Cleveland Clinic
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Time to Successfully Intubate Patient.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Macintosh blade
Intubation with Macintosh blade laryngoscope
Intervention: Macintosh blade (Device)
Glidescope
Intubation with Glidescope laryngoscope
Intervention: Glidescope (Device)
Truview PCD
Intubation with the Truview PCD laryngoscope
Intervention: Truview PCD (Device)
Outcomes
Primary Outcomes
Time to Successfully Intubate Patient.
Time Frame: from start of intubation to successfully intubated up to 5 minutes
Secondary Outcomes
- 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.)
- Mean Hemodynamic Response: Heart Rate(measured at 1 minute interval at induction time and from intubation for 10 minutes.)