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The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| McGrath Videolaryngoscope for rapid endotracheal intubation | Experimental | The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation. |
|
| Efficacy of conventional direct laryngoscopy | Other | The researchers seek to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| McGrath videolaryngoscope for rapid sequence endotracheal intubation | Device | Visualize a patient's airway to aid placement of tracheal tube with ease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From the start time of intubation to time of the end of surgery, up to 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1, 2, 3, and 4 Intubation Attempts | An intubation attempt was recorded once the endotracheal tube entered the oral cavity | From the start time of intubation to time of the end of surgery, up to 12 hours. |
| Intubation Failure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Ruetzler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Health Science, Bakirkoy Dr. Sadi Konuk Education, and Research Hospital, | Istanbul | Turkey (Türkiye) | ||||
Randomization data were missing for n = 6 patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | From the start time of intubation to time of the end of surgery, up to 12 hours. |
|
From the start time of intubation to the end of the surgery, up to 12 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| YanYan Han | Cleveland Clinic Foundation | 216-444-2250 | HANY3@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2022 | Aug 14, 2024 | Prot_SAP_000.pdf |
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| Conventional direct laryngoscopy using a Macintosh blade | Device | Examine a patient's airway to aid placement of tracheal tube with ease. |
|
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. |
| From the start time of intubation to time of the end of surgery, up to 12 hours. |
| The University of Health Science, Konya City Hospital |
| Konya |
| Turkey (Türkiye) |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Gender data for one patient is missing in Direct laryngoscopy group | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Study center | Number | participants |
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| BMI | Median | Inter-Quartile Range | kg/m^2 |
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| History of difficult airway | This data for one patient is missing in Direct laryngoscopy group | Count of Participants | Participants |
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| Mallampati score | The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group | Count of Participants | Participants |
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| ASA physical status | This data for one patient is missing in Direct laryngoscopy group | Count of Participants | Participants |
|
| OG001 | 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. |
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| 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 | 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. | Posted | Count of Participants | Participants | From the start time of intubation to time of the end of surgery, up to 12 hours. |
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| 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. | Posted | Count of Participants | Participants | From the start time of intubation to time of the end of surgery, up to 12 hours. |
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| 0 |
| 193 |
| 0 |
| 193 |
| 0 |
| 193 |
| EG001 | 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. | 0 | 201 | 0 | 201 | 0 | 201 |
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| 3 intubation attempts |
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| 4 intubation attempts |
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