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The Use of the GlideScope Ranger in Pediatric Critical Care Transport

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GlideScope Ranger Intubation
Direct Laryngoscopy
Sponsored by
Akron Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring respiratory failure, intubation, GlideScope, pediatric

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Akron Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intubation using GlideScope Ranger

intubation using direct laryngoscopy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percent of Participants With Successful 1st Intubation Attempt
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).
Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).

Secondary Outcome Measures

Full Information

First Posted
January 21, 2010
Last Updated
February 4, 2015
Sponsor
Akron Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01054183
Brief Title
The Use of the GlideScope Ranger in Pediatric Critical Care Transport
Official Title
The Use of the GlideScope Ranger in Pediatric Critical Care Transport
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akron Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
respiratory failure, intubation, GlideScope, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intubation using GlideScope Ranger
Arm Type
Experimental
Arm Description
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.
Arm Title
intubation using direct laryngoscopy
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
GlideScope Ranger Intubation
Intervention Description
Intubation with GlideScope Ranger Video Laryngoscope
Intervention Type
Device
Intervention Name(s)
Direct Laryngoscopy
Intervention Description
Intubations will be done with direct laryngoscopy.
Primary Outcome Measure Information:
Title
Percent of Participants With Successful 1st Intubation Attempt
Description
Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)
Time Frame
30 days
Title
Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL).
Description
Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).
Time Frame
30 days; no long-term outcome measures were included

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael T Bigham, M.D.
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16179054
Citation
Cooper RM. The GlideScope videolaryngoscope. Anaesthesia. 2005 Oct;60(10):1042. doi: 10.1111/j.1365-2044.2005.04384.x. No abstract available.
Results Reference
background
PubMed Identifier
15644017
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. doi: 10.1111/j.1365-2044.2004.04038.x.
Results Reference
background
PubMed Identifier
19059923
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.
Results Reference
background
PubMed Identifier
15601274
Citation
Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. doi: 10.1111/j.1365-2044.2004.04013.x.
Results Reference
background
PubMed Identifier
18689807
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.
Results Reference
background
PubMed Identifier
17474957
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. doi: 10.1111/j.1460-9592.2006.02149.x.
Results Reference
background
PubMed Identifier
18349622
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-238e. doi: 10.1097/01.prs.0000305397.19883.a7. No abstract available.
Results Reference
background
PubMed Identifier
16575049
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. doi: 10.1007/BF03022520. No abstract available.
Results Reference
background
Citation
Nichols, D.G. and M.C. Rogers, Rogers' textbook of pediatric intensive care. 4th ed. 2008, Philadelpia: Lippincott Williams & Wilkins. No PMID Available.
Results Reference
background
Citation
04/14/2009 [cited 2009 June]; Available from: http://www.aap.org/sections/transmed/DatabaseTM.pdf
Results Reference
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The Use of the GlideScope Ranger in Pediatric Critical Care Transport

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