Airway Management, Intubation
Conditions
Keywords
Video laryngoscopy, Intubation success, Difficult airway, CMAC laryngoscope
Brief summary
This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult.
Detailed description
Patients will be specifically screened for predictors by history and physical exam of potential airway difficulty. The role of video laryngoscopy in airways predicted to be difficult is poorly defined. This study aims to recognize if video laryngoscopy is more useful than conventional laryngoscopy as a first attempt for those with anticipated difficulty.
Interventions
DEVICECMAC video laryngoscope
Intubation utilizing the assistance of video enhancement
DEVICEMacintosh laryngoscope
Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors: * mallampati classification 3 * mallampati classification 4 * Reduced mouth opening (\<3cm) * reduced cervical motion * history of previous difficult intubation or multiple laryngoscopy attempts
Exclusion criteria
* Patients less than 18 years old, patients who are not fasted (\>6 hrs. NPO) * Patients who have contraindications to the administration of neuromuscular blocking drugs * Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view * Patients who are deemed to difficult and dangerous to anesthetize without first securing an airway.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Intubation Success | During each intubation in a 14 month period | Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time | During laryngoscopy procedure | Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation |
| Number of Participants Intubated With a Rescue Device | 1 year | — |
| Number of Participants With Complications | 1 year | — |
| Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | 1 year | Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved |
| Number of Particpants Requiring Adjuncts to Assist Intubation | 1 year | — |
Countries
United States
Participant flow
Recruitment details
Patients were recruited at OHSU OR and procedure rooms. 300 patients were enrolled in the study from 10/09-12/10
Pre-assignment details
4 exclusions were noted for failure to follow the randomization
Participants by arm
| Arm | Count |
|---|---|
| CMAC Video Laryngoscope Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion | 150 |
| Macintosh Blade Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion | 150 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 3 |
Baseline characteristics
| Characteristic | Macintosh Blade | CMAC Video Laryngoscope | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 28 Participants | 64 Participants |
| Age, Categorical Between 18 and 65 years | 114 Participants | 122 Participants | 236 Participants |
| Age, Continuous | 55.4 years STANDARD_DEVIATION 14.5 | 53.8 years STANDARD_DEVIATION 14.2 | 54.6 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment United States | 150 participants | 150 participants | 300 participants |
| Sex: Female, Male Female | 65 Participants | 76 Participants | 141 Participants |
| Sex: Female, Male Male | 85 Participants | 74 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 150 | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 |
Outcome results
Primary
Measure of Intubation Success
Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure
Time frame: During each intubation in a 14 month period
Population: 4 patients of the 300 were excluded because the randomization was not followed due to unavailability of equipment or provider preference to remove patient from study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CMAC Video Laryngoscope | Measure of Intubation Success | 138 Participants |
| Macintosh Blade | Measure of Intubation Success | 124 Participants |
Secondary
Intubation Time
Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation
Time frame: During laryngoscopy procedure
Population: time
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CMAC Video Laryngoscope | Intubation Time | 46 seconds |
| Macintosh Blade | Intubation Time | 33 seconds |
Secondary
Number of Participants Intubated With a Rescue Device
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CMAC Video Laryngoscope | Number of Participants Intubated With a Rescue Device | 6 participants |
| Macintosh Blade | Number of Participants Intubated With a Rescue Device | 12 participants |
Secondary
Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.
Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CMAC Video Laryngoscope | Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade I view achieved | 103 Participants |
| CMAC Video Laryngoscope | Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade 2 view achieved | 36 Participants |
| CMAC Video Laryngoscope | Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade 3 view achieved | 9 Participants |
| CMAC Video Laryngoscope | Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade 4 view achieved | 1 Participants |
| Macintosh Blade | Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade 4 view achieved | 2 Participants |
| Macintosh Blade | Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade I view achieved | 72 Participants |
| Macintosh Blade | Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade 3 view achieved | 26 Participants |
| Macintosh Blade | Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade 2 view achieved | 47 Participants |
Secondary
Number of Participants With Complications
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CMAC Video Laryngoscope | Number of Participants With Complications | 35 Participants |
| Macintosh Blade | Number of Participants With Complications | 26 Participants |
Secondary
Number of Particpants Requiring Adjuncts to Assist Intubation
Time frame: 1 year
Population: Use of bougie or external manipulation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CMAC Video Laryngoscope | Number of Particpants Requiring Adjuncts to Assist Intubation | 33 Participants |
| Macintosh Blade | Number of Particpants Requiring Adjuncts to Assist Intubation | 46 Participants |