Not provided
Not provided
Not provided
Not provided
Not provided
The study was stopped for futility at the first interim analysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope devices, Glidescope and Truview provide better laryngeal views in pediatric patients as measured by Cormack and ehane (C&L) (1 to 4, 4 the worst), without increasing the time taken to intubate (TTI), compared with direct laryngoscopy (DL).
The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke less hemodynamic response and fewer episodes of de-saturation in pediatric patients.
Advances in airway management have led to development on videolaryngoscopy devices including the Glidescope® (Verathon Inc, Bothwell, USA), the AWD® (Pentax Corporation, Tokio, Japan) and most recently the Truview PCD (Truphatek International Ltd, Netanya, Israel). The use of videolaryngoscopy devices in adults have demonstrated some advantages including, minimal trauma on the airway and better view of the glottis.
The Glidescope is designed with a 60º angle and a camera on the inferior aspect just at the inflection point. The view is obtained anteriorly and the camera is located remote from the glottis providing a good visual field. The video image is displayed on a Liquid Crystal Display (LCD), with electronic recording available. Despite a good experience using Glidescope in adults, few studies have been published in pediatric patients. Kim et al. in a randomized study comparing the use of Glidescope with direct laryngoscopy in children, demonstrated better or equal laryngoscopic view with longer time for intubation using the Glidescope.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macintosh blade | Active Comparator | Intubation with Macintosh blade laryngoscope |
|
| Glidescope | Active Comparator | Intubation with Glidescope laryngoscope |
|
| Truview PCD | Active Comparator | Intubation with the Truview PCD laryngoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macintosh blade | Device | Intubation with Macintosh blade laryngoscope |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Successfully Intubate Patient. | from start of intubation to successfully intubated up to 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Hemodynamic Response: Mean Arterial Blood Pressure | measured at 1 minute interval at induction time and from intubation for 10 minutes | |
| Cormack-Lehane Grade | immediately after intubation | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julie Niezgoda, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Macintosh Blade | Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope |
| FG001 | Glidescope | Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope. |
| FG002 | Truview PCD | Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Macintosh Blade | Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope |
| BG001 | Glidescope | Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to Successfully Intubate Patient. | Posted | Median | Inter-Quartile Range | seconds | from start of intubation to successfully intubated up to 5 minutes |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Macintosh Blade | Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta Johnson | Cleveland Clinic | 216-444-9950 | johnsor13@ccf.org |
Not provided
Not provided
Not provided
Not provided
Not provided
| Glidescope |
| Device |
Intubation with Glidescope laryngoscope. |
|
| Truview PCD | Device | Intubation with Truview PCD laryngoscope. |
|
| Mean Hemodynamic Response: Heart Rate |
| measured at 1 minute interval at induction time and from intubation for 10 minutes. |
| Number of Participants Who Experienced Desaturation | Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after | measured at 1 minute interval at induction time and from intubation for 10 minutes. |
| BG002 | Truview PCD | Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Body mass index | Median | Inter-Quartile Range | kg/m2 |
|
| ASA physical status | Number | participants |
|
|
|
|
| Secondary | Mean Hemodynamic Response: Mean Arterial Blood Pressure | Posted | Mean | Standard Deviation | mmHg | measured at 1 minute interval at induction time and from intubation for 10 minutes |
|
|
|
|
| Secondary | Cormack-Lehane Grade | Posted | Number | participants | immediately after intubation |
|
|
|
|
| Secondary | Mean Hemodynamic Response: Heart Rate | Posted | Mean | Standard Deviation | beats/min | measured at 1 minute interval at induction time and from intubation for 10 minutes. |
|
|
|
|
| Secondary | Number of Participants Who Experienced Desaturation | Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after | Posted | Number | participants | measured at 1 minute interval at induction time and from intubation for 10 minutes. |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Glidescope | Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope. | 0 | 44 | 0 | 44 |
| EG002 | Truview PCD | Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope. | 0 | 45 | 0 | 45 |
Not provided
Not provided
|
| 3: Only epiglottis seen, none of glottis seen |
|
| 4: Neither glottis nor epiglottis seen |
|
| The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome. | Wilcoxon (Mann-Whitney) | 1-tailed Wilcoxon sum-rank test | 0.18 | Median Difference (Final Values) | 0 | 2-Sided | 95 | 0 | 0 | The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS "NPAR1WAY" procedure was used for test and estimation. | No | Superiority or Other |