NCT01054183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 5, 2015

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

January 21, 2010

Results QC Date

November 28, 2012

Last Update Submit

February 4, 2015

Conditions

Respiratory Failure

Keywords

respiratory failure, intubation, GlideScope, pediatric

Outcome Measures

Primary Outcomes (2)

  • Percent of Participants With Successful 1st Intubation Attempt

    Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)

    30 days

  • 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

Study Arms (2)

Intubation using GlideScope Ranger

EXPERIMENTAL

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 using direct laryngoscopy

ACTIVE COMPARATOR

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

Interventions

GlideScope Ranger IntubationDEVICE

Intubation with GlideScope Ranger Video Laryngoscope

Intubation using GlideScope Ranger
Direct LaryngoscopyDEVICE

Intubations will be done with direct laryngoscopy.

intubation using direct laryngoscopy

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Patients 18+ years of age
  • Patient has a functioning tracheostomy
  • Patient does not require orotracheal intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Related Publications (10)

  • Cooper RM. The GlideScope videolaryngoscope. Anaesthesia. 2005 Oct;60(10):1042. doi: 10.1111/j.1365-2044.2005.04384.x. No abstract available.

    PMID: 16179054BACKGROUND

  • 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.

    PMID: 15644017BACKGROUND

  • 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.

    PMID: 19059923BACKGROUND

  • 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.

    PMID: 15601274BACKGROUND

  • 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.

    PMID: 18689807BACKGROUND

  • 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.

    PMID: 17474957BACKGROUND

  • 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.

    PMID: 18349622BACKGROUND

  • 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.

    PMID: 16575049BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Limitations and Caveats

The biggest limitation was slow patient enrollment, prompting the study to be closed prior to reaching the full study power. All data were reliably reported.

Results Point of Contact

Title
Michael T. Bigham, MD
Organization
Akron Children's Hospital
MBigham@chmca.org
330-543-8639

Study Officials

  • Michael T Bigham, M.D.

    Akron Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

February 23, 2015

Results First Posted

February 5, 2015

Record last verified: 2015-02

Locations

US(1)