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


Condition Intervention Phase
Respiratory Failure
Device: GlideScope Ranger Intubation
Device: Direct Laryngoscopy
Phase 4

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:


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

Primary Outcome Measures:
  • Number of attempts to successful intubation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: July 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 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
  More Information

Publications:
Responsible Party: Michael T. Bigham, MD, MD, Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT01054183     History of Changes
Other Study ID Numbers: 090903
Study First Received: January 21, 2010
Last Updated: November 7, 2011
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 August 18, 2014