Intubation
Conditions
Keywords
intubation, pediatric, videolaryngoscope devices
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMacintosh blade
Intubation with Macintosh blade laryngoscope
DEVICEGlidescope
Intubation with Glidescope laryngoscope.
DEVICETruview PCD
Intubation with Truview PCD laryngoscope.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I-III * elective general surgical procedures * from 0-10 years-old
Exclusion criteria
* increase intracranial pressure * history of severe gastrointestinal reflux * sore throat * upper respiratory airway infection * known or suspected difficult airway or coagulopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Successfully Intubate Patient. | from start of intubation to successfully intubated up to 5 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Hemodynamic Response: Heart Rate | measured at 1 minute interval at induction time and from intubation for 10 minutes. | — |
| 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 | — |
| Number of Participants Who Experienced Desaturation | measured at 1 minute interval at induction time and from intubation for 10 minutes. | Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Macintosh Blade Intubation with Macintosh blade laryngoscope
Macintosh blade: Intubation with Macintosh blade laryngoscope | 45 |
| Glidescope Intubation with Glidescope laryngoscope
Glidescope: Intubation with Glidescope laryngoscope. | 44 |
| Truview PCD Intubation with the Truview PCD laryngoscope
Truview PCD: Intubation with Truview PCD laryngoscope. | 45 |
| Total | 134 |
Baseline characteristics
| Characteristic | Macintosh Blade | Glidescope | Truview PCD | Total |
|---|---|---|---|---|
| Age, Continuous | 4.0 years STANDARD_DEVIATION 2.8 | 4.6 years STANDARD_DEVIATION 2.7 | 5.2 years STANDARD_DEVIATION 2.8 | 4.6 years STANDARD_DEVIATION 2.8 |
| ASA physical status I: A normal healthy patient | 19 participants | 20 participants | 19 participants | 58 participants |
| ASA physical status II: A patient with mild systemic disease | 24 participants | 23 participants | 25 participants | 72 participants |
| ASA physical status III: A patient with severe systemic disease | 2 participants | 1 participants | 1 participants | 4 participants |
| Body mass index | 17 kg/m2 | 16 kg/m2 | 16 kg/m2 | 16.5 kg/m2 |
| Gender Female | 16 Participants | 11 Participants | 14 Participants | 41 Participants |
| Gender Male | 29 Participants | 33 Participants | 31 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 44 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 44 | 0 / 45 |
Outcome results
Primary
Time to Successfully Intubate Patient.
Time frame: from start of intubation to successfully intubated up to 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Macintosh Blade | Time to Successfully Intubate Patient. | 23 seconds |
| Glidescope | Time to Successfully Intubate Patient. | 39 seconds |
| Truview PCD | Time to Successfully Intubate Patient. | 44 seconds |
p-value: >0.9995% CI: [7, 26]Wilcoxon (Mann-Whitney)
p-value: >0.9995% CI: [6, 28]Wilcoxon (Mann-Whitney)
Secondary
Cormack-Lehane Grade
Time frame: immediately after intubation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macintosh Blade | Cormack-Lehane Grade | 4: Neither glottis nor epiglottis seen | 0 participants |
| Macintosh Blade | Cormack-Lehane Grade | 3: Only epiglottis seen, none of glottis seen | 5 participants |
| Macintosh Blade | Cormack-Lehane Grade | 1: Full view of glottis | 34 participants |
| Macintosh Blade | Cormack-Lehane Grade | 2: Partial view of glottis | 6 participants |
| Glidescope | Cormack-Lehane Grade | 1: Full view of glottis | 6 participants |
| Glidescope | Cormack-Lehane Grade | 2: Partial view of glottis | 13 participants |
| Glidescope | Cormack-Lehane Grade | 3: Only epiglottis seen, none of glottis seen | 23 participants |
| Glidescope | Cormack-Lehane Grade | 4: Neither glottis nor epiglottis seen | 2 participants |
| Truview PCD | Cormack-Lehane Grade | 3: Only epiglottis seen, none of glottis seen | 1 participants |
| Truview PCD | Cormack-Lehane Grade | 1: Full view of glottis | 37 participants |
| Truview PCD | Cormack-Lehane Grade | 2: Partial view of glottis | 7 participants |
| Truview PCD | Cormack-Lehane Grade | 4: Neither glottis nor epiglottis seen | 0 participants |
Comparison: The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.p-value: >0.9995% CI: [1, 2]Wilcoxon (Mann-Whitney)
Comparison: The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.p-value: 0.1895% CI: [0, 0]Wilcoxon (Mann-Whitney)
Secondary
Mean Hemodynamic Response: Heart Rate
Time frame: measured at 1 minute interval at induction time and from intubation for 10 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macintosh Blade | Mean Hemodynamic Response: Heart Rate | 126 beats/min | Standard Deviation 21 |
| Glidescope | Mean Hemodynamic Response: Heart Rate | 127 beats/min | Standard Deviation 15 |
| Truview PCD | Mean Hemodynamic Response: Heart Rate | 128 beats/min | Standard Deviation 18 |
p-value: 0.26ANOVA
Secondary
Mean Hemodynamic Response: Mean Arterial Blood Pressure
Time frame: measured at 1 minute interval at induction time and from intubation for 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macintosh Blade | Mean Hemodynamic Response: Mean Arterial Blood Pressure | 62 mmHg | Standard Deviation 12 |
| Glidescope | Mean Hemodynamic Response: Mean Arterial Blood Pressure | 63 mmHg | Standard Deviation 9 |
| Truview PCD | Mean Hemodynamic Response: Mean Arterial Blood Pressure | 66 mmHg | Standard Deviation 12 |
p-value: 0.28ANOVA
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
Time frame: measured at 1 minute interval at induction time and from intubation for 10 minutes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macintosh Blade | Number of Participants Who Experienced Desaturation | 1 participants |
| Glidescope | Number of Participants Who Experienced Desaturation | 0 participants |
| Truview PCD | Number of Participants Who Experienced Desaturation | 1 participants |
p-value: >0.99Chi-squared