Respiratory FailureNCT01054183

The Use of the GlideScope Ranger in Pediatric Critical Care Transport

A study testing GlideScope Ranger Intubation and Direct Laryngoscopy in people with Respiratory Failure, run by Akron Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 17 years
Conditions the study is for: Respiratory Failure
What is being tested?: GlideScope Ranger Intubation and Direct Laryngoscopy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Dec 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Akron Children's Hospital
Akron, Ohio, 44308

Other trials in United States

About this study

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.

Conditions: Respiratory Failure
Being tested: GlideScope Ranger Intubation, Direct Laryngoscopy
Keywords: respiratory failure, intubation, GlideScope, pediatric
Medical subject headings: Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GlideScope Ranger IntubationDevice
Intubation with GlideScope Ranger Video Laryngoscope
Direct LaryngoscopyDevice
Intubations will be done with direct laryngoscopy.

Study groups in NCT01054183
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Direct Laryngoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Participants With Successful 1st Intubation Attempt
Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)
Measured: 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).
Measured: 30 days; no long-term outcome measures were included

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Dec 2011

First posted22 Jan 2010 (estimated)
Study startJul 2010
Primary completionNov 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Respiratory FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01054183
Sponsor's protocol ID: 090903
Status last verified: Feb 2015
First submitted: 21 Jan 2010
Last updated: 23 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cooper RM. The GlideScope videolaryngoscope. Anaesthesia. 2005 Oct;60(10):1042. doi: 10.1111/j.1365-2044.2005.04384.x. No abstract available.
PubMed 16179054
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.
PubMed 15644017
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.
PubMed 19059923
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.
PubMed 15601274
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.
PubMed 18689807
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.
PubMed 17474957
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.
PubMed 18349622
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.
PubMed 16575049
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of the GlideScope Ranger in Pediatric Critical Care Transport
ClinicalTrials.gov ID: NCT01054183
Acronym / sponsor ID: 090903
Conditions: Respiratory Failure
Keywords: respiratory failure, intubation, GlideScope, pediatric
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Akron Children's HospitalUniversity, hospital or other
Study start: Jul 2010
Primary completion: Nov 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 22 Jan 2010 (estimated)
Results: Posted 5 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intubation using GlideScope Ranger	Experimental	Device: GlideScope Ranger IntubationThe 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.
intubation using direct laryngoscopy	Active comparator	Device: Direct LaryngoscopyThe 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.

Who may qualify

Ages: Up to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GlideScope Ranger IntubationIntubation with GlideScope Ranger Video Laryngoscope	Device	Intubation using GlideScope Ranger
Direct LaryngoscopyIntubations will be done with direct laryngoscopy.	Device	intubation using direct laryngoscopy

Primary outcome

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)
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).

Results and safety

Results posted to the registry on 5 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GlideScope Ranger Intubation	10	10
Direct Laryngoscopy Intubation	12	12

Primary outcome: Percent of Participants With Successful 1st Intubation Attempt

Time frame: 30 days. Number. Unit: Percent of Participants

Measure	GlideScope Ranger Intubation n = 10	Direct Laryngoscopy Intubation n = 12
Value	30	41.67

GlideScope Ranger Intubation vs Direct Laryngoscopy Intubation: p = 0.57, z test, two-sided

Primary outcome: Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL).

Time frame: 30 days; no long-term outcome measures were included. Number. Unit: Percent of successful intubations

Measure	GlideScope Ranger Intubation n = 10	Direct Laryngoscopy Intubation n = 12
Value	26.3	64.3

GlideScope Ranger Intubation vs Direct Laryngoscopy Intubation: p = 0.002, z test, two-sided

Population analysed: The study was powered for 62 patients per study arm. Due to slow patient enrollment, the study was stopped prior to full enrollment with the aforementioned 22 total patients.

Adverse events

Time frame: 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GlideScope Video Laryngoscope Ranger(GVL)	0 of 10 (0%)	6 of 10 (60%)	Not reported
Direct Laryngoscopy	0 of 12 (0%)	4 of 12 (33.3%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16179054Cooper RM. The GlideScope videolaryngoscope. Anaesthesia. 2005 Oct;60(10):1042. doi: 10.1111/j.1365-2044.2005.04384.x. No abstract available.
Background: PubMed 15644017Lim 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.
Background: PubMed 19059923Malik 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.
Background: PubMed 15601274Rai 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.
Background: PubMed 18689807Kim 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.
Background: PubMed 17474957Milne 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.
Background: PubMed 18349622Taub 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.
Background: PubMed 16575049Trevisanuto 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.
BackgroundNichols, D.G. and M.C. Rogers, Rogers' textbook of pediatric intensive care. 4th ed. 2008, Philadelpia: Lippincott Williams & Wilkins. No PMID Available.
Background04/14/2009 [cited 2009 June]; Available from: http://www.aap.org/sections/transmed/DatabaseTM.pdf

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Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
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Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael T Bigham, M.D. principal investigator

Akron Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GlideScope Ranger Intubation and Direct Laryngoscopy in people with Respiratory Failure, run by Akron Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants With Successful 1st Intubation Attempt (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01054183, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.