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

This study has been terminated.

Sponsor:

Information provided by:

Outcomes Research Consortium

ClinicalTrials.gov Identifier:

NCT01023568

First received: December 1, 2009

Last updated: September 13, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 1, 2009
Last Updated Date	September 13, 2011
Start Date ^ICMJE	December 2009
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 7, 2010)	Time to successfully intubate patient. [ Time Frame: 60 seconds ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 1, 2009)	Time to succesfully intubate patient. [ Time Frame: 60 seconds ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01023568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 13, 2011)	time to intubation [ Time Frame: 60 seconds ] [ Designated as safety issue: No ] GS and TV will be tested for mean hemodynamic response and equivalency (to each other) on both time to intubation (equivalency delta of 7 seconds) and proportion with Cormack score of 1 (equivalency delta of 0.05). proportion of intubation with Cormack score of 1 [ Time Frame: 60 seconds ] [ Designated as safety issue: No ] GS and TV will be tested for mean hemodynamic response and equivalency (to each other) on both time to intubation (equivalency delta of 7 seconds) and proportion with Cormack score of 1 (equivalency delta of 0.05).
Original Secondary Outcome Measures ^ICMJE (submitted: December 1, 2009)	GS and TV will be tested for mean hemodynamic response and equivalency (to each other) on both time to intubation (equivalency delta of 7 seconds) and proportion with Cormack score of 1 (equivalency delta of 0.05). [ Time Frame: 60 seconds ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients
Official Title ^ICMJE	Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care
Condition ^ICMJE	Intubation
Intervention ^ICMJE	Device: Macintosh blade Intubation with Macintosh blade laryngoscope Device: Glidescope Intubation with Glidescope laryngoscope. Device: Truview PCD Intubation with Truview PCD laryngoscope.
Study Arm (s)	Active Comparator: Macintosh blade Intubation with Macintosh blade laryngoscope Intervention: Device: Macintosh blade Active Comparator: Glidescope Intubation with Glidescope laryngoscope Intervention: Device: Glidescope Active Comparator: Truview PCD Intubation with the Truview PCD laryngoscope Intervention: Device: Truview PCD
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	134
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	up to 10 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01023568
Other Study ID Numbers ^ICMJE	09-902
Has Data Monitoring Committee	No
Responsible Party	Julie Niezgoda, MD, Cleveland Clinic
Study Sponsor ^ICMJE	Outcomes Research Consortium
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Outcomes Research Consortium
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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