Respiratory Failure
Conditions
Keywords
respiratory failure, intubation, GlideScope, pediatric
Brief summary
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.
Interventions
DEVICEGlideScope Ranger Intubation
Intubation with GlideScope Ranger Video Laryngoscope
DEVICEDirect Laryngoscopy
Intubations will be done with direct laryngoscopy.
Sponsors
Akron Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Successful 1st Intubation Attempt | 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). | 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). |
Countries
United States
Participant flow
Recruitment details
Prospectively enrolled 22 patients between 8/1/2010 - 5/1/2012.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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. | 12 |
| Total | 22 |
Baseline characteristics
| Characteristic | Direct Laryngoscopy Intubation | GlideScope Ranger Intubation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 10 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.5 years STANDARD_DEVIATION 3.02 | 2.1 years STANDARD_DEVIATION 4.56 | 1.8 years STANDARD_DEVIATION 3.71 |
| Region of Enrollment United States | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 10 | 4 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 |
Outcome results
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).
Time frame: 30 days; no long-term outcome measures were included
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GlideScope Ranger Intubation | Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL). | 26.3 Percent of successful intubations |
| Direct Laryngoscopy Intubation | Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL). | 64.3 Percent of successful intubations |
Comparison: Null hypothesis: overall successful intubation rate is the same for both groups.p-value: 0.002z test, two-sided
Primary
Percent of Participants With Successful 1st Intubation Attempt
Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GlideScope Ranger Intubation | Percent of Participants With Successful 1st Intubation Attempt | 30 Percent of Participants |
| Direct Laryngoscopy Intubation | Percent of Participants With Successful 1st Intubation Attempt | 41.67 Percent of Participants |
Comparison: Null hypothesis: the proportion of successful 1st intubation attempt is the same for both groupsp-value: 0.57z test, two-sided