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

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ClinicalTrials.gov Identifier: NCT01023568
Recruitment Status : Terminated (The study was stopped for futility at the first interim analysis)
First Posted : December 2, 2009
Results First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Intubation Device: Macintosh blade Device: Glidescope Device: Truview PCD Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients
Study Start Date : December 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Active Comparator: Macintosh blade
Intubation with Macintosh blade laryngoscope
Device: Macintosh blade
Intubation with Macintosh blade laryngoscope

Active Comparator: Glidescope
Intubation with Glidescope laryngoscope
Device: Glidescope
Intubation with Glidescope laryngoscope.

Active Comparator: Truview PCD
Intubation with the Truview PCD laryngoscope
Device: Truview PCD
Intubation with Truview PCD laryngoscope.




Primary Outcome Measures :
  1. Time to Successfully Intubate Patient. [ Time Frame: from start of intubation to successfully intubated up to 5 minutes ]

Secondary Outcome Measures :
  1. Mean Hemodynamic Response: Mean Arterial Blood Pressure [ Time Frame: measured at 1 minute interval at induction time and from intubation for 10 minutes ]
  2. Cormack-Lehane Grade [ Time Frame: immediately after intubation ]
  3. Mean Hemodynamic Response: Heart Rate [ Time Frame: measured at 1 minute interval at induction time and from intubation for 10 minutes. ]
  4. Number of Participants Who Experienced Desaturation [ Time Frame: 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



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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023568


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Julie Niezgoda, MD The Cleveland Clinic

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01023568     History of Changes
Other Study ID Numbers: 09-902
First Posted: December 2, 2009    Key Record Dates
Results First Posted: February 2, 2017
Last Update Posted: February 2, 2017
Last Verified: December 2016

Keywords provided by The Cleveland Clinic:
intubation
pediatric
videolaryngoscope devices