Intubation, Laryngoscopy
Conditions
Keywords
Airway, Videolaryngoscope, Direct Laryngoscope
Brief summary
The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. The additional cost might be justified if video systems improve intubation success and reduce airway trauma. But if they do not, the extra cost would not be justified
Detailed description
The investigators propose to enroll participants scheduled for elective or emergent cardiac, thoracic, or vascular surgery in the designated operating room suite who require endotracheal intubation for general anesthesia. A cluster randomized multiple crossover design is used for this trial. The cardiac surgical suites will be divided into 2 sets of 11 operating rooms. Each set is treated as a unit and randomized to receive video or direct laryngoscopy in 1-week blocks, always with 1 set randomized to each approach. For analysis, each operating room within a set will be considered a separate cluster. Randomization will be conducted weekly on a 1:1 unstratified basis, using computer-generated codes maintained in a web-based system. Investigators access these codes a day before each new treatment block begins.
Interventions
DEVICEGlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)
After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, Washington 98011) is an FDA-cleared commercially available portable videolaryngoscope.
DEVICEDirect laryngoscopy
After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Cluster randomized multiple crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia.
Exclusion criteria
* The attending anesthesiologist prefers a specific approach for a particular patient * Awake fiberoptic intubation is clinically indicated * Insertion of double-lumen tube.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. | From the start time of intubation to time of the end of surgery up to 24 hours. | Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Failure | From the start time of intubation to time of the end of surgery. | Intubation failure is defined by the responsible clinician switching to an alternative laryngoscopy device for any reason at any time, or by more than 3 intubation attempts. |
| Any Dental or Airway Injury | From the start time of intubation to time of the end of surgery. | Airway injury is defined as any bleeding or apparent injury to the lips, mouth, pharynx, vocal cords, or other airway structures recorded by the anesthesia team. Dental injury is defined as any apparent injury to the teeth as recorded by the anesthesia team. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maximum Mean Arterial Pressure | In five minutes after intubation. | Maximum mean arterial pressure (MAP) in the five minutes after intubation |
| Maximum Heart Rate (HR) | In five minutes after intubation | Maximum heart rate in the five minutes after intubation |
Countries
United States
Participant flow
Pre-assignment details
The Protocol Enrollment (N = 7,736) is 172 less than the calculated total number of participants Started (N = 7908), because these patients were enrolled more than once and assigned to different clusters due to having multiple operations in designated operating rooms during the study.
Participants by arm
| Arm | Count |
|---|---|
| Videolaryngoscopy Initial intubation performed using GlideScope videolaryngoscope.
GlideScope videolaryngoscope (Verathon, Bothell, WA 98011): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope. | 4,196 |
| Videolaryngoscopy Initial intubation performed using GlideScope videolaryngoscope.
GlideScope videolaryngoscope (Verathon, Bothell, WA 98011): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope. | 4,413 |
| Conventional Direct Laryngoscopy Initial intubation performed using direct laryngoscopy.
Direct laryngoscopy: After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4); | 3,819 |
| Conventional Direct Laryngoscopy Initial intubation performed using direct laryngoscopy.
Direct laryngoscopy: After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4); | 4,016 |
| Total | 16,444 |
Baseline characteristics
| Characteristic | Conventional Direct Laryngoscopy | Total | Videolaryngoscopy |
|---|---|---|---|
| Admission category Elective | 3424 surgical procedure | 7135 surgical procedure | 3711 surgical procedure |
| Admission category Emergent | 592 surgical procedure | 1294 surgical procedure | 702 surgical procedure |
| Age, Continuous | 63 years STANDARD_DEVIATION 14 | 63 years STANDARD_DEVIATION 14 | 63 years STANDARD_DEVIATION 13 |
| ASA (American Society of Anesthesiologists) physical status 1 (Healthy) | 14 surgical procedure | 20 surgical procedure | 6 surgical procedure |
| ASA (American Society of Anesthesiologists) physical status 2 (Mild systemic illness) | 94 surgical procedure | 168 surgical procedure | 74 surgical procedure |
| ASA (American Society of Anesthesiologists) physical status 3 (Severe systemic illness) | 668 surgical procedure | 1362 surgical procedure | 694 surgical procedure |
| ASA (American Society of Anesthesiologists) physical status 4 (Life-threatening systemic illness) | 3211 surgical procedure | 6816 surgical procedure | 3605 surgical procedure |
| ASA (American Society of Anesthesiologists) physical status 5 (Not expected to survive without the operation) | 29 surgical procedure | 63 surgical procedure | 34 surgical procedure |
| BMI | 28 kg/m2 STANDARD_DEVIATION 6 | 28 kg/m2 STANDARD_DEVIATION 6.5 | 29 kg/m2 STANDARD_DEVIATION 6.5 |
| History of difficult intubation within past 5 years | 112 surgical procedure | 250 surgical procedure | 138 surgical procedure |
| Level of first intubation clinician Attending anesthesiologist | 112 surgical procedure | 225 surgical procedure | 113 surgical procedure |
| Level of first intubation clinician CRNA | 1611 surgical procedure | 3283 surgical procedure | 1672 surgical procedure |
| Level of first intubation clinician Fellow | 582 surgical procedure | 1185 surgical procedure | 603 surgical procedure |
| Level of first intubation clinician Medical student | 18 surgical procedure | 47 surgical procedure | 29 surgical procedure |
| Level of first intubation clinician Resident | 1157 surgical procedure | 2514 surgical procedure | 1357 surgical procedure |
| Level of first intubation clinician SRNA | 536 surgical procedure | 1175 surgical procedure | 639 surgical procedure |
| Mallampati score III (Soft palate, base of uvula visible) | 453 surgical procedure | 1113 surgical procedure | 660 surgical procedure |
| Mallampati score II (Soft palate, major part of uvula visible) | 2406 surgical procedure | 4989 surgical procedure | 2583 surgical procedure |
| Mallampati score I (Soft palate, uvula, pillars visible) | 1109 surgical procedure | 2187 surgical procedure | 1078 surgical procedure |
| Mallampati score IV (Only hard palate visible) | 24 surgical procedure | 88 surgical procedure | 64 surgical procedure |
| Mallampati score Missing | 24 surgical procedure | 52 surgical procedure | 28 surgical procedure |
| Race/Ethnicity, Customized Black | 410 surgical procedure | 821 surgical procedure | 411 surgical procedure |
| Race/Ethnicity, Customized Missing | 146 surgical procedure | 322 surgical procedure | 176 surgical procedure |
| Race/Ethnicity, Customized Other | 167 surgical procedure | 338 surgical procedure | 171 surgical procedure |
| Race/Ethnicity, Customized White/Caucasian | 3293 surgical procedure | 6948 surgical procedure | 3655 surgical procedure |
| Sex: Female, Male Female | 2599 surgical procedure | 5479 surgical procedure | 2880 surgical procedure |
| Sex: Female, Male Male | 1417 surgical procedure | 2950 surgical procedure | 1533 surgical procedure |
| Surgery type Cardiac | 2934 surgical procedure | 6251 surgical procedure | 3317 surgical procedure |
| Surgery type Other | 453 surgical procedure | 927 surgical procedure | 474 surgical procedure |
| Surgery type Thoracic | 69 surgical procedure | 132 surgical procedure | 63 surgical procedure |
| Surgery type Vascular | 560 surgical procedure | 1119 surgical procedure | 559 surgical procedure |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4,413 | 0 / 4,016 |
| other Total, other adverse events | 0 / 4,413 | 0 / 4,016 |
| serious Total, serious adverse events | 0 / 4,413 | 0 / 4,016 |
Outcome results
Primary
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated.
Time frame: From the start time of intubation to time of the end of surgery up to 24 hours.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Videolaryngoscopy | The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. | 1 | 4336 Surgical procedures |
| Videolaryngoscopy | The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. | 2 | 70 Surgical procedures |
| Videolaryngoscopy | The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. | 3 | 3 Surgical procedures |
| Videolaryngoscopy | The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. | >3 | 4 Surgical procedures |
| Conventional Direct Laryngoscopy | The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. | >3 | 2 Surgical procedures |
| Conventional Direct Laryngoscopy | The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. | 1 | 3710 Surgical procedures |
| Conventional Direct Laryngoscopy | The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. | 3 | 27 Surgical procedures |
| Conventional Direct Laryngoscopy | The Number of Intubation Attempts With the Initial Laryngoscopy Instrument. | 2 | 277 Surgical procedures |
p-value: <0.00199.32% CI: [0.14, 0.29]GLM cumulative logit GEE model
Secondary
Any Dental or Airway Injury
Airway injury is defined as any bleeding or apparent injury to the lips, mouth, pharynx, vocal cords, or other airway structures recorded by the anesthesia team. Dental injury is defined as any apparent injury to the teeth as recorded by the anesthesia team.
Time frame: From the start time of intubation to time of the end of surgery.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Videolaryngoscopy | Any Dental or Airway Injury | 41 Surgical procedures |
| Conventional Direct Laryngoscopy | Any Dental or Airway Injury | 42 Surgical procedures |
p-value: 0.5399.32% CI: [0.48, 1.58]GLM log-binomial model (log link)
Secondary
Intubation Failure
Intubation failure is defined by the responsible clinician switching to an alternative laryngoscopy device for any reason at any time, or by more than 3 intubation attempts.
Time frame: From the start time of intubation to time of the end of surgery.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Videolaryngoscopy | Intubation Failure | 12 Surgical procedures |
| Conventional Direct Laryngoscopy | Intubation Failure | 161 Surgical procedures |
p-value: <0.00199.32% CI: [0.03, 0.14]Wilcoxon (Mann-Whitney)
Other Pre-specified
Maximum Heart Rate (HR)
Maximum heart rate in the five minutes after intubation
Time frame: In five minutes after intubation
Population: N = 26 procedures had missing HR in Videolaryngoscopy group; N = 17 procedures had missing HR in Direct laryngoscopy group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videolaryngoscopy | Maximum Heart Rate (HR) | 83 beats/min | Standard Deviation 18 |
| Conventional Direct Laryngoscopy | Maximum Heart Rate (HR) | 83 beats/min | Standard Deviation 18 |
p-value: 0.2795% CI: [-0.34, 1.2]Mixed Models Analysis
Other Pre-specified
Maximum Mean Arterial Pressure
Maximum mean arterial pressure (MAP) in the five minutes after intubation
Time frame: In five minutes after intubation.
Population: N = 64 surgical procedures had missing MAP in the Videolaryngoscopy group; N = 39 procedures had missing MAP in the Direct laryngoscopy group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videolaryngoscopy | Maximum Mean Arterial Pressure | 107 mmHg | Standard Deviation 24 |
| Conventional Direct Laryngoscopy | Maximum Mean Arterial Pressure | 105 mmHg | Standard Deviation 24 |
p-value: <0.00195% CI: [0.92, 3.1]Mixed Models Analysis