Laminectomy
Conditions
Keywords
C-MAC, Fiberoptic bronchoscope, Laryngoscopy, Cervical spine injury, Glottic view, Tracheal intubation
Brief summary
The purpose of this study is to evaluate whether tracheal intubation with the CMAC device decreases the time required for intubation as compared to intubation with the fiberoptic bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the fiberoptic bronchoscope are currently commonly used in standard of care practices in the intubation of patients with cervical spine injury.
Interventions
DEVICEFiberoptic bronchoscope
Fiberoptic bronchoscope device
DEVICECMAC
CMAC Device
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with an unstable Cervical-spine as a result of C-spine injury. * Patients scheduled to undergo inpatient surgical procedures under general anesthesia. * Willingness and ability to sign an informed consent document. * 18-80 years of age. * ASA Class I - III adults of either sex
Exclusion criteria
* Patients deemed to be at significant airway risk to necessitate awake fiber optic intubation. * Patients with a history of oral-pharyngeal cancer or reconstructive surgery. * Emergency surgeries. * Any other conditions which may interfere with the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time (Seconds) | 3 minutes | Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube |
| Time to Confirm the Placement of the Tracheal Tube | up tp 3 minutes | It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Obtain Glottis Visualization (Seconds) | 1 minute | Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CMAC Device CMAC
CMAC: CMAC Device | 70 |
| Fiberoptic Bronchoscope Fiberoptic bronchoscope
Fiberoptic bronchoscope: Fiberoptic bronchoscope device | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | CMAC Device | Fiberoptic Bronchoscope | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 12 | 50 years STANDARD_DEVIATION 12 | 53 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 70 participants | 70 participants | 140 participants |
| Sex: Female, Male Female | 32 Participants | 38 Participants | 70 Participants |
| Sex: Female, Male Male | 38 Participants | 32 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Intubation Time (Seconds)
Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube
Time frame: 3 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CMAC Device | Intubation Time (Seconds) | 35 Seconds | Standard Deviation 22 |
| Flexible Fiberoptic Scope (FFS) | Intubation Time (Seconds) | 59 Seconds | Standard Deviation 36 |
Primary
Time to Confirm the Placement of the Tracheal Tube
It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform
Time frame: up tp 3 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CMAC Device | Time to Confirm the Placement of the Tracheal Tube | 62 Seconds | Standard Deviation 31 |
| Flexible Fiberoptic Scope (FFS) | Time to Confirm the Placement of the Tracheal Tube | 99 Seconds | Standard Deviation 38 |
Secondary
Time to Obtain Glottis Visualization (Seconds)
Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine.
Time frame: 1 minute
Population: Time to Obtain Glottis Visualization (Seconds) Glottic visualization during the beginning of the intubation procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CMAC Device | Time to Obtain Glottis Visualization (Seconds) | 32 Seconds | Standard Deviation 32 |
| Flexible Fiberoptic Scope (FFS) | Time to Obtain Glottis Visualization (Seconds) | 16 Seconds | Standard Deviation 14 |