Surgery
Conditions
Brief summary
The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
Detailed description
The study aims to conduct a multicenter international trial to enroll a maximum of 800 consenting adults who fall under the American Society of Anesthesiologists (ASA) physical status 1-3 category and require elective non-cardiac surgery necessitating endotracheal intubation with rapid sequence induction for general anesthesia. The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
Interventions
DEVICEMcGrath videolaryngoscope for rapid sequence endotracheal intubation
Visualize a patient's airway to aid placement of tracheal tube with ease.
DEVICEConventional direct laryngoscopy using a Macintosh blade
Examine a patient's airway to aid placement of tracheal tube with ease.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Elective surgery requiring oral endotracheal intubation for general anesthesia; * Anticipated extubation in the operating room; * American Society of Anesthesiologists (ASA) physical status 2-3; * Age between 18 and 99 years; * Body Mass index ≥ 40 kg/m2.
Exclusion criteria
* Refusal of participation by attending anesthesiologist; * Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration * Indicated fiberoptic awake intubation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visualization of the Vocal Cords | From the start time of intubation to time of the end of surgery, up to 12 hours. | The visualization of the vocal cords, defined using the modified Cormack and Lehane classification: Grade I: Full view of the glottis (vocal cords are completely visible). Grade IIa: Partial view of the glottis (only the posterior portion of the glottis is visible). Grade IIb: Only the arytenoids or the posterior extremity of the vocal cords are visible (the anterior commissure is not seen). Grade III: Only the epiglottis is visible (the glottis is not visible). Grade IV: Neither the epiglottis nor the glottis is visible (only the soft palate is seen). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 1, 2, 3, and 4 Intubation Attempts | From the start time of intubation to time of the end of surgery, up to 12 hours. | An intubation attempt was recorded once the endotracheal tube entered the oral cavity |
| Intubation Failure. | From the start time of intubation to time of the end of surgery, up to 12 hours. | Intubation was considered a failure if there was: (1) a failure to intubate after 3 attempts, (2) the need to switch intubators or intubation device, or (3) the need to stop study per anesthesiologist's discretion. |
Countries
Turkey (Türkiye)
Participant flow
Pre-assignment details
Randomization data were missing for n = 6 patients.
Participants by arm
| Arm | Count |
|---|---|
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
McGrath videolaryngoscope for rapid sequence endotracheal intubation: Visualize a patient's airway to aid placement of tracheal tube with ease. | 193 |
| Efficacy of Conventional Direct Laryngoscopy The researchers seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade,
Conventional direct laryngoscopy using a Macintosh blade: Examine a patient's airway to aid placement of tracheal tube with ease. | 201 |
| Total | 394 |
Baseline characteristics
| Characteristic | McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Efficacy of Conventional Direct Laryngoscopy | Total |
|---|---|---|---|
| Age, Continuous | 46 years | 46 years | 46 years |
| ASA physical status 1 (Healthy) | 41 Participants | 39 Participants | 80 Participants |
| ASA physical status 2 (Mild systemic illness) | 124 Participants | 135 Participants | 259 Participants |
| ASA physical status 3 (Severe systemic illness) | 28 Participants | 26 Participants | 54 Participants |
| BMI | 28 kg/m^2 | 28 kg/m^2 | 28 kg/m^2 |
| History of difficult airway No | 187 Participants | 193 Participants | 380 Participants |
| History of difficult airway Yes | 6 Participants | 7 Participants | 13 Participants |
| Mallampati score III (Soft palate, base of uvula visible) | 39 Participants | 35 Participants | 74 Participants |
| Mallampati score II (Soft palate, major part of uvula visible) | 89 Participants | 104 Participants | 193 Participants |
| Mallampati score I (Soft palate, uvula, pillars visible | 59 Participants | 54 Participants | 113 Participants |
| Mallampati score IV (Only hard palate visible | 5 Participants | 3 Participants | 8 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 119 Participants | 109 Participants | 228 Participants |
| Sex: Female, Male Male | 74 Participants | 91 Participants | 165 Participants |
| Study center Istanbul | 96 participants | 104 participants | 200 participants |
| Study center Konya | 97 participants | 97 participants | 194 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 193 | 0 / 201 |
| other Total, other adverse events | 0 / 193 | 0 / 201 |
| serious Total, serious adverse events | 0 / 193 | 0 / 201 |
Outcome results
Primary
Visualization of the Vocal Cords
The visualization of the vocal cords, defined using the modified Cormack and Lehane classification: Grade I: Full view of the glottis (vocal cords are completely visible). Grade IIa: Partial view of the glottis (only the posterior portion of the glottis is visible). Grade IIb: Only the arytenoids or the posterior extremity of the vocal cords are visible (the anterior commissure is not seen). Grade III: Only the epiglottis is visible (the glottis is not visible). Grade IV: Neither the epiglottis nor the glottis is visible (only the soft palate is seen).
Time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Visualization of the Vocal Cords | Grade IIa - Partial view of the glottis | 63 Participants |
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Visualization of the Vocal Cords | Grade III - Only the epiglottis is visible | 10 Participants |
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Visualization of the Vocal Cords | Grade IIb - Only the arytenoids or the posterior extremity of the vocal cords are visible | 26 Participants |
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Visualization of the Vocal Cords | Grade IV - Neither the epiglottis nor the glottis is visible | 4 Participants |
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Visualization of the Vocal Cords | Grade I - Full view of the glottis | 90 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Visualization of the Vocal Cords | Grade IV - Neither the epiglottis nor the glottis is visible | 4 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Visualization of the Vocal Cords | Grade I - Full view of the glottis | 85 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Visualization of the Vocal Cords | Grade IIa - Partial view of the glottis | 67 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Visualization of the Vocal Cords | Grade IIb - Only the arytenoids or the posterior extremity of the vocal cords are visible | 28 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Visualization of the Vocal Cords | Grade III - Only the epiglottis is visible | 17 Participants |
p-value: 0.2695% CI: [0.85, 1.79]proportional-odds cumulative logit model
Secondary
Intubation Failure.
Intubation was considered a failure if there was: (1) a failure to intubate after 3 attempts, (2) the need to switch intubators or intubation device, or (3) the need to stop study per anesthesiologist's discretion.
Time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Intubation Failure. | 3 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Intubation Failure. | 1 Participants |
p-value: 0.3695% CI: [0.32, 30]Fisher Exact
Secondary
Number of Participants With 1, 2, 3, and 4 Intubation Attempts
An intubation attempt was recorded once the endotracheal tube entered the oral cavity
Time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.
Population: N = 4 patients were missing the number of attempts in the McGrath Videolaryngoscope group. N = 3 patients were missing the number of attempts in the Direct Laryngoscopy group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Number of Participants With 1, 2, 3, and 4 Intubation Attempts | 1 intubation attempt | 167 Participants |
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Number of Participants With 1, 2, 3, and 4 Intubation Attempts | 2 intubation attempts | 21 Participants |
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Number of Participants With 1, 2, 3, and 4 Intubation Attempts | 3 intubation attempts | 0 Participants |
| McGrath Videolaryngoscope for Rapid Endotracheal Intubation | Number of Participants With 1, 2, 3, and 4 Intubation Attempts | 4 intubation attempts | 1 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Number of Participants With 1, 2, 3, and 4 Intubation Attempts | 4 intubation attempts | 0 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Number of Participants With 1, 2, 3, and 4 Intubation Attempts | 1 intubation attempt | 176 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Number of Participants With 1, 2, 3, and 4 Intubation Attempts | 3 intubation attempts | 1 Participants |
| Efficacy of Conventional Direct Laryngoscopy | Number of Participants With 1, 2, 3, and 4 Intubation Attempts | 2 intubation attempts | 21 Participants |
p-value: 0.8697.5% CI: [0.82, 1.27]proportional-odds cumulative logit model