The Use of the GlideScope Ranger in Pediatric Critical Care Transport - Full Text View

Purpose

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 Ranger video laryngoscopy and using conventional, direct laryngoscopy by pediatric and neonatal critical care transport teams.

Condition	Intervention
Respiratory Failure	Device: GlideScope Ranger Intubation Device: Direct Laryngoscopy


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Use of the GlideScope Ranger in Pediatric Critical Care Transport

Resource links provided by NLM:

MedlinePlus related topics: Critical Care Respiratory Failure

U.S. FDA Resources

Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:

Percent of Participants With Successful 1st Intubation Attempt [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)
Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL). [ Time Frame: 30 days; no long-term outcome measures were included ] [ Designated as safety issue: No ]
Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).


Enrollment:	22
Study Start Date:	July 2010
Study Completion Date:	December 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Device: GlideScope Ranger Intubation Intubation with GlideScope Ranger Video Laryngoscope
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.	Device: Direct Laryngoscopy Intubations will be done with direct laryngoscopy.

Eligibility


Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054183

Locations


United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308

Sponsors and Collaborators

Akron Children's Hospital

Investigators


Principal Investigator:	Michael T Bigham, M.D.	Akron Children's Hospital

More Information

Publications:

Cooper RM. The GlideScope videolaryngoscope. Anaesthesia. 2005 Oct;60(10):1042.

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. doi: 10.1093/bja/aen342.

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. doi: 10.1093/bja/aen234. 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. doi: 10.1097/01.prs.0000305397.19883.a7.

Trevisanuto D, Fornaro E, Verghese C. The GlideScope video laryngoscope: initial experience in five neonates. Can J Anaesth. 2006 Apr;53(4):423-4.


Responsible Party:	Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT01054183 History of Changes
Other Study ID Numbers:	090903
Study First Received:	January 21, 2010
Results First Received:	November 28, 2012
Last Updated:	February 4, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:


respiratory failure, intubation, GlideScope, pediatric

Additional relevant MeSH terms:


Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 25, 2015