King Vision Video Laryngoscope Intubation, Pediatric Anesthesia
Conditions
Brief summary
This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal intubations.
Interventions
The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.
Sponsors
King Systems Corporation
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 10 Years
Healthy volunteers
No
Inclusion criteria
1. All children between the ages of 1 month to 10 years with a normal preoperative airway examination 2. Scheduled for a surgical procedure that requires tracheal intubation shall be included.
Exclusion criteria
1\. Patients that will be excluded are those with an airway examination or previous anesthesia history that suggests difficulty with mask ventilation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Endotracheal Intubation | During intubation | Ease of endotracheal intubation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Participant details | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 100 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 100 participants | — |
| Sex: Female, Male Female | 45 Participants | — |
| Sex: Female, Male Male | 55 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
Ease of Endotracheal Intubation
Ease of endotracheal intubation
Time frame: During intubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ease of Endotracheal Tube Passage | Ease of Endotracheal Intubation | 65 participants |