The Use of the GlideScope Ranger in Pediatric Critical Care Transport

Respiratory Failure Clinical Trial

Official title:

The Use of the GlideScope Ranger in Pediatric Critical Care Transport

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054183
• Other study ID #: 090903
• Status: Completed
• Phase: N/A
• First received: January 21, 2010
• Last updated: February 4, 2015
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2015
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Akron Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (10)

04/14/2009 [cited 2009 June]; Available from: http://www.aap.org/sections/transmed/DatabaseTM.pdf

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nichols, D.G. and M.C. Rogers, Rogers' textbook of pediatric intensive care. 4th ed. 2008, Philadelpia: Lippincott Williams & Wilkins. No PMID Available.

Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. — View Citation

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. — View Citation

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

Outcome

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