The Use of the GlideScope Ranger in Pediatric Critical Care Transport
This study has been completed.
Sponsor:
Akron Children's Hospital
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT01054183
First received: January 21, 2010
Last updated: February 4, 2015
Last verified: February 2015
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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 Ranger video laryngoscopy and using conventional, direct laryngoscopy by pediatric and neonatal critical care transport teams.
| Condition | Intervention |
|---|---|
|
Respiratory Failure |
Device: GlideScope Ranger Intubation Device: Direct Laryngoscopy |
| 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:
- Percent of Participants With Successful 1st Intubation Attempt [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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). [ Time Frame: 30 days; no long-term outcome measures were included ] [ Designated as safety issue: No ]Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).
| Enrollment: | 22 |
| Study Start Date: | July 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | November 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 (Child) |
| 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
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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
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
Investigators
| Principal Investigator: | Michael T Bigham, M.D. | Akron Children's Hospital |
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 |
| Study First Received: | January 21, 2010 |
| Results First Received: | November 28, 2012 |
| Last Updated: | February 4, 2015 |
| 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 September 28, 2016