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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlideScope Ranger Intubation | Device | Intubation with GlideScope Ranger Video Laryngoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael T Bigham, M.D. | Akron Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16179054 | Background | Cooper RM. The GlideScope videolaryngoscope. Anaesthesia. 2005 Oct;60(10):1042. doi: 10.1111/j.1365-2044.2005.04384.x. No abstract available. | |
| 15644017 | Background | 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. |
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Prior to the initiation of the study, staff received didactic and simulation based instruction with the Glidescope Video Laryngoscope (GVL) and demonstrated competency through a minimum of 5 successful intubations in patients >10 kg and 1 intubation in a patient < or = 10 Kg in a controlled operating room setting.
Prospectively enrolled 22 patients between 8/1/2010 - 5/1/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | GlideScope Ranger Intubation | 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. GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope |
| FG001 | Direct Laryngoscopy Intubation | 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. Direct Laryngoscopy : Intubations will be done with direct laryngoscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GlideScope Ranger Intubation | 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. GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Participants With Successful 1st Intubation Attempt | Percent of participants with successful 1st intubation attempt by group (GVL vs. DL) | Posted | Number | Percent of Participants | 30 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GlideScope Video Laryngoscope Ranger(GVL) | Procedure used to perform tracheal intubation that facilitates indirect visualization of the glottis through a video display. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secretions | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael T. Bigham, MD | Akron Children's Hospital | 330-543-8639 | MBigham@chmca.org |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Direct Laryngoscopy | Device | Intubations will be done with direct laryngoscopy. |
|
| 19059923 | Background | 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. |
| 15601274 | Background | 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. |
| 18689807 | Background | 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. |
| 17474957 | Background | 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. |
| 18349622 | Background | 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. |
| 16575049 | Background | 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. |
| Background | 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 |
| Direct Laryngoscopy Intubation |
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. Direct Laryngoscopy : Intubations will be done with direct laryngoscopy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | 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). | 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. | Posted | Number | Percent of successful intubations | 30 days; no long-term outcome measures were included | total intubation attempts | Participants |
|
|
|
|
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Direct Laryngoscopy | Procedure used to visualize the vocal cords and perform tracheal intubation in the pediatric and neonatal population. | 0 | 12 | 4 | 12 |
| Insufficient view | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Difficult passing ETT with stylet | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Patient movement | Nervous system disorders | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Wrong size blade | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tube size inappropriate | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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