Intubation; Difficult, Cervical Spine Injury
Conditions
Keywords
Storz C-Mac®, Pediatric Airway, Cervical Spine Injury, Trauma Airway Management
Brief summary
The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will result in less head motion and therefore less cervical motion when compared with direct laryngoscopy (DL). The aim of the study is to determine the amount of head motion (extension, flexion and rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily, the study will also measure the number of attempts to properly intubate and the time required for intubation with either technique.
Detailed description
Investigator initiated single site prospective and randomized controlled trial.
Interventions
PROCEDUREVideo Laryngoscopy
Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
PROCEDUREDirect Laryngoscopy
Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
DEVICEStorz C-Mac® laryngoscope
Sponsors
Florida International University
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Years
Healthy volunteers
No
Inclusion criteria
* patients being orally intubated in the Operating Room as per standard anesthesia procedures
Exclusion criteria
* previous history of cervical spine injury or surgery * craniofacial abnormalities * airway congenital abnormalities * airway prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Head Motion - Extension or Flexion | During the process of intubation (less than one minute) | Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for Intubation | During the process of intubation (less than one minute) | Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Video Laryngoscopy Some patients will be intubated with a video laryngoscope
Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Storz C-Mac® laryngoscope | 46 |
| Direct Laryngoscopy Some patients will be intubated with a direct (conventional) laryngoscope
Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Storz C-Mac® laryngoscope | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | Video Laryngoscopy | Direct Laryngoscopy | Total |
|---|---|---|---|
| Age, Continuous | 4.0 years STANDARD_DEVIATION 1.8 | 4.07 years STANDARD_DEVIATION 1.9 | 4.04 years STANDARD_DEVIATION 1.8 |
| Head Motion in degrees Extension | 17.7 participants STANDARD_DEVIATION 11.1 | 16.5 participants STANDARD_DEVIATION 9.5 | 17.05 participants STANDARD_DEVIATION 10.18 |
| Head Motion in degrees Flexion | 9.6 participants STANDARD_DEVIATION 8 | 8.3 participants STANDARD_DEVIATION 5.8 | 8.95 participants STANDARD_DEVIATION 6.9 |
| Head Motion in degrees Rotation Left | 6.2 participants STANDARD_DEVIATION 4.4 | 6.5 participants STANDARD_DEVIATION 7 | 6.40 participants STANDARD_DEVIATION 5.76 |
| Head Motion in degrees Rotation Right | 9.1 participants STANDARD_DEVIATION 7.6 | 7.9 participants STANDARD_DEVIATION 6.6 | 8.48 participants STANDARD_DEVIATION 7.02 |
| Sex: Female, Male Female | 24 Participants | 22 Participants | 46 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
Primary
Head Motion - Extension or Flexion
Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that.
Time frame: During the process of intubation (less than one minute)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video Laryngoscopy | Head Motion - Extension or Flexion | 16.5 degrees of extension | Standard Deviation 9.5 |
| Direct Laryngoscopy | Head Motion - Extension or Flexion | 17.7 degrees of extension | Standard Deviation 11.1 |
Secondary
Time for Intubation
Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that.
Time frame: During the process of intubation (less than one minute)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video Laryngoscopy | Time for Intubation | 25.8 second | Standard Deviation 18.4 |
| Direct Laryngoscopy | Time for Intubation | 18.9 second | Standard Deviation 10.8 |