The Use of the GlideScope Ranger in Pediatric Critical Care Transport

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Michael T. Bigham, MD, Akron Children's Hospital

ClinicalTrials.gov Identifier:

NCT01054183

First received: January 21, 2010

Last updated: November 7, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 21, 2010
Last Updated Date	November 7, 2011
Start Date ^ICMJE	July 2010
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 21, 2010)	Number of attempts to successful intubation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01054183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Use of the GlideScope Ranger in Pediatric Critical Care Transport
Official Title ^ICMJE	The Use of the GlideScope Ranger in Pediatric Critical Care Transport
Brief Summary	This study seeks to assess the role of the GlideScope Ranger video laryngoscope in facilitating successful neonatal/pediatric intubation by pediatric critical care transport teams. The central hypothesis of this study is that the GlideScope Ranger video laryngoscope reduces the rates of failed intubation attempts by pediatric critical care transport teams. The aims of this project are designed to specifically: (1) Establish competencies for GlideScope Ranger video laryngoscopy-assisted intubation for pediatric and neonatal patients; and (2) Compare the intubation success rates for intubation using GlideScope Ranter video laryngoscopy and using conventional, direct laryngoscopy by pediatric and neonatal critical care transport teams.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Respiratory Failure
Intervention ^ICMJE	Device: GlideScope Ranger Intubation Intubation with GlideScope Ranger Video Laryngoscope Device: Direct Laryngoscopy Intubations will be done with direct laryngoscopy.
Study Arm (s)	Experimental: Intubation using GlideScope Ranger The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day. Intervention: Device: GlideScope Ranger Intubation Active Comparator: intubation using direct laryngoscopy The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day. Intervention: Device: Direct Laryngoscopy
Publications *	Cooper RM. The GlideScope videolaryngoscope. Anaesthesia. 2005 Oct;60(10):1042. No abstract available. Lim TJ, Lim Y, Liu EH. Evaluation of ease of intubation with the GlideScope or Macintosh laryngoscope by anaesthetists in simulated easy and difficult laryngoscopy. Anaesthesia. 2005 Feb;60(2):180-3. Malik MA, O'Donoghue C, Carney J, Maharaj CH, Harte BH, Laffey JG. Comparison of the Glidescope, the Pentax AWS, and the Truview EVO2 with the Macintosh laryngoscope in experienced anaesthetists: a manikin study. Br J Anaesth. 2009 Jan;102(1):128-34. Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. Kim JT, Na HS, Bae JY, Kim DW, Kim HS, Kim CS, Kim SD. GlideScope video laryngoscope: a randomized clinical trial in 203 paediatric patients. Br J Anaesth. 2008 Oct;101(4):531-4. Epub 2008 Aug 8. Milne AD, Dower AM, Hackmann T. Airway management using the pediatric GlideScope in a child with Goldenhar syndrome and atypical plasma cholinesterase. Paediatr Anaesth. 2007 May;17(5):484-7. Taub PJ, Silver L, Gooden CK. Use of the GlideScope for airway management in patients with craniofacial anomalies. Plast Reconstr Surg. 2008 Apr;121(4):237e-8e. No abstract available. Trevisanuto D, Fornaro E, Verghese C. The GlideScope video laryngoscope: initial experience in five neonates. Can J Anaesth. 2006 Apr;53(4):423-4. No abstract available.
* 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	Enrolling by invitation
Estimated Enrollment ^ICMJE	96
Estimated Completion Date	June 2012
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: age < 18 years Presence of respiratory failure requiring tracheal intubation by the Critical Care Transport Team either at the referring institution or during the transport to the receiving institution Ability of parent or legal guardian to provide written informed consent Exclusion Criteria: Patients 18+ years of age Patient has a functioning tracheostomy Patient does not require orotracheal intubation
Gender	Both
Ages	up to 17 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	NCT01054183
Other Study ID Numbers ^ICMJE	090903
Has Data Monitoring Committee	Yes
Responsible Party	Michael T. Bigham, MD, Akron Children's Hospital
Study Sponsor ^ICMJE	Akron Children's Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Akron Children's Hospital
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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