ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of the GlideScope Ranger in Pediatric Critical Care Transport

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01054183
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : February 5, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: GlideScope Ranger Intubation Device: Direct Laryngoscopy Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of the GlideScope Ranger in Pediatric Critical Care Transport
Study Start Date : July 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percent of Participants With Successful 1st Intubation Attempt [ Time Frame: 30 days ]
    Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)

  2. Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL). [ Time Frame: 30 days; no long-term outcome measures were included ]
    Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Nichols, D.G. and M.C. Rogers, Rogers' textbook of pediatric intensive care. 4th ed. 2008, Philadelpia: Lippincott Williams & Wilkins. No PMID Available.
04/14/2009 [cited 2009 June]; Available from: http://www.aap.org/sections/transmed/DatabaseTM.pdf

Responsible Party: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT01054183     History of Changes
Other Study ID Numbers: 090903
First Posted: January 22, 2010    Key Record Dates
Results First Posted: February 5, 2015
Last Update Posted: February 23, 2015
Last Verified: February 2015

Keywords provided by Akron Children's Hospital:
respiratory failure, intubation, GlideScope, pediatric

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases