Intubation
Conditions
Keywords
Neonate, Laryngoscopes
Brief summary
The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.
Detailed description
We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.
Interventions
DEVICEMiller Laryngoscope
Device is used to facilitate tracheal intubation.
DEVICEGlidescope Cobalt Video Laryngoscopes
The laryngoscope design with the integration of video technology into the laryngoscope blade.
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
1. Scheduled to undergo elective surgery at CHOP 2. American Society of Anesthesiologists (ASA) Physical Status I or II 3. Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant 4. Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -
Exclusion criteria
1. At known or anticipated high risk for aspiration pneumonia 2. Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist 3. Emergency surgical procedure 4. Patients with preoperative airway pathology or stridor -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Tracheal Intubation | Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation. | The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system. |
Countries
United States
Participant flow
Recruitment details
Healthy infants under the age of 12 months undergoing elective surgery requiring tracheal intubation were eligible.
Pre-assignment details
Any subject was excluded from participation if they were known or suspected to be a difficult intubation or if they required a rapid-sequence intubation.
Participants by arm
| Arm | Count |
|---|---|
| Direct Laryngoscopy Approach Subjects were randomly assigned to an arm. | 33 |
| Glidescope Videoscope Approach Subjects were randomly assigned to an arm. | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | Glidescope Videoscope Approach | Direct Laryngoscopy Approach | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 33 Participants | 66 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 | 0.492 years STANDARD_DEVIATION 0.283 | 0.425 years STANDARD_DEVIATION 0.275 | 0.459 years STANDARD_DEVIATION 0.279 |
| Region of Enrollment United States | 33 participants | 33 participants | 66 participants |
| Sex: Female, Male Female | 5 Participants | 13 Participants | 18 Participants |
| Sex: Female, Male Male | 28 Participants | 20 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time to Tracheal Intubation
The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.
Time frame: Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Direct Laryngoscopy Approach | Time to Tracheal Intubation | 21.4 seconds |
| Glidescope Videoscope Approach | Time to Tracheal Intubation | 22.6 seconds |