Difficult Airway
Conditions
Keywords
difficult airway, video laryngoscopy
Brief summary
This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology.
Interventions
DEVICEC-MAC
C-MAC arm
DEVICEGlidescope
Glidescope arm
Sponsors
University of Iowa
The University of Texas Health Science Center, Houston
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* adult 18 years of age * Mallampati classification scale score of 3 or 4 * Neck circumference greater than 40cm for males, 38 cm for females * mouth opening less than 3cm, but greater than 2cm
Exclusion criteria
* children * prisoners * history of easy intubation (success on first attempt with direct laryngoscopy) * known unstable cervical spine injury * emergency surgery * nasal intubation route * planned awake technique
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Success Rate | 1 week | Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time | 1 week | Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide |
| Graded Score of Laryngeal View Achieved | 1 week | Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view. |
| Number of Particpants Requiring Adjuncts to Assist Intubation | 1 week | The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team. |
| Number of Participants With Observed Complications | 1 week | Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| C-MAC Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation
C-MAC: C-MAC arm | 548 |
| Glidescope Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation
Glidescope: Glidescope arm | 552 |
| Total | 1,100 |
Baseline characteristics
| Characteristic | C-MAC | Glidescope | Total |
|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 13.7 | 54.4 years STANDARD_DEVIATION 14.1 | 53.7 years STANDARD_DEVIATION 13.9 |
| Sex: Female, Male Female | 292 Participants | 267 Participants | 559 Participants |
| Sex: Female, Male Male | 256 Participants | 285 Participants | 541 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 548 | 7 / 552 |
| serious Total, serious adverse events | 0 / 548 | 0 / 552 |
Outcome results
Primary
Intubation Success Rate
Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C-MAC | Intubation Success Rate | 512 participants |
| Glidescope | Intubation Success Rate | 531 participants |
Secondary
Graded Score of Laryngeal View Achieved
Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view.
Time frame: 1 week
Population: Cormack-Lehane grade
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C-MAC | Graded Score of Laryngeal View Achieved | Grade 1 | 482 participants |
| C-MAC | Graded Score of Laryngeal View Achieved | Grade 2 | 41 participants |
| C-MAC | Graded Score of Laryngeal View Achieved | Grade 3 | 8 participants |
| C-MAC | Graded Score of Laryngeal View Achieved | Grade 4 | 10 participants |
| Glidescope | Graded Score of Laryngeal View Achieved | Grade 4 | 2 participants |
| Glidescope | Graded Score of Laryngeal View Achieved | Grade 1 | 398 participants |
| Glidescope | Graded Score of Laryngeal View Achieved | Grade 3 | 11 participants |
| Glidescope | Graded Score of Laryngeal View Achieved | Grade 2 | 146 participants |
Secondary
Intubation Time
Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide
Time frame: 1 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| C-MAC | Intubation Time | 47 seconds |
| Glidescope | Intubation Time | 47 seconds |
Secondary
Number of Participants With Observed Complications
Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| C-MAC | Number of Participants With Observed Complications | 97 Participants |
| Glidescope | Number of Participants With Observed Complications | 85 Participants |
Secondary
Number of Particpants Requiring Adjuncts to Assist Intubation
The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| C-MAC | Number of Particpants Requiring Adjuncts to Assist Intubation | 117 Participants |
| Glidescope | Number of Particpants Requiring Adjuncts to Assist Intubation | 128 Participants |