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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| videolaryngoscopy | Experimental | Initial intubation performed using GlideScope videolaryngoscope. |
|
| conventional direct laryngoscopy | Active Comparator | Initial intubation performed using direct laryngoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start time of intubation to time of the end of surgery up to 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start time of intubation to time of the end of surgery. |
| Any Dental or Airway Injury |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Mean Arterial Pressure | Maximum mean arterial pressure (MAP) in the five minutes after intubation | In five minutes after intubation. |
| Maximum Heart Rate (HR) | Maximum heart rate in the five minutes after intubation |
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 |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38497992 | Derived | Ruetzler K, Bustamante S, Schmidt MT, Almonacid-Cardenas F, Duncan A, Bauer A, Turan A, Skubas NJ, Sessler DI; Collaborative VLS Trial Group. Video Laryngoscopy vs Direct Laryngoscopy for Endotracheal Intubation in the Operating Room: A Cluster Randomized Clinical Trial. JAMA. 2024 Apr 16;331(15):1279-1286. doi: 10.1001/jama.2024.0762. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cluster 1: Operating Suites 60 to 70 | A cluster randomized multiple crossover design was used for this trial. The cardiac surgical suite was divided into 2 sets of 11 operating rooms each (cluster 1: operating suites 60 to 70, and cluster 2: operating suites 71 to 81). These sets are the clusters. All operations performed in these operating suites were assessed for eligibility. N= 172 patients were enrolled more than once and assigned to different clusters due to having multiple operations. Each week, one set of ORs was randomly assigned to video laryngoscopy, while the other set was assigned to direct laryngoscopy. At the beginning of each week, the randomization occurred again, so in the following week, the set of ORs that had video laryngoscopy might now be assigned to direct laryngoscopy, and vice versa. This randomization continues for 90 weeks, with each set of ORs potentially receiving a different intervention each week. For analysis, each operating room within a set was considered a separate cluster. Randomization was conducted weekly on a 1:1 unstratified basis, using computer-generated codes maintained in a web-based system. Investigators accessed these codes a day before each new treatment block began. N=1,945 patients with 1,995 operations were enrolled into cluster 1 during the 42 direct laryngoscopy periods (Randomization occurs weekly for 90 weeks). Additionally, 2,418 patients with 2,486 operations were enrolled in cluster 1 during the 48 video laryngoscopy periods. |
| FG001 | Cluster 2: Operating Suites 71 to 81 | A total of 1,916 patients with 2,021 operations were enrolled into cluster 2 during the 48 direct laryngoscopy periods (Randomization occurs weekly for 90 weeks). Additionally, 1,828 patients with 1,927 operations were enrolled into cluster 2 during the 42 video laryngoscopy periods (Randomization occurs weekly for 90 weeks). In patients randomized to videolaryngoscopy, initial intubation was 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Count of Units | Surgical procedures | From the start time of intubation to time of the end of surgery up to 24 hours. | Surgical procedures | Surgical procedures |
|
From the start time of intubation to time of the end of surgery up to 24 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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Ruetzler | Cleveland Clinic | 216 407-4108 | ruetzlk@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 | Mar 27, 2022 | Mar 18, 2024 | Prot_SAP_000.pdf |
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Cluster randomized multiple crossover design
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|
| Direct laryngoscopy | Device | 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); |
|
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. |
| From the start time of intubation to time of the end of surgery. |
| In five minutes after intubation |
| BG001 | 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); |
| BG002 | Total | Total of all reporting groups |
| surgical procedure |
|
| years |
| surgical procedure |
|
|
| Sex: Female, Male | Count of Units | surgical procedure | surgical procedure |
|
|
| Race/Ethnicity, Customized | Count of Units | surgical procedure | surgical procedure |
|
|
| BMI | One missing in each group | Mean | Standard Deviation | kg/m2 | surgical procedure |
|
|
| Admission category | Count of Units | surgical procedure | surgical procedure |
|
|
| Surgery type | Count of Units | surgical procedure | surgical procedure |
|
|
| ASA (American Society of Anesthesiologists) physical status | Count of Units | surgical procedure | surgical procedure |
|
|
| Level of first intubation clinician | Count of Units | surgical procedure | surgical procedure |
|
|
| Mallampati score | To describe the relative size of the base of the tongue compared to the oropharyngeal opening in hopes of predicting the difficult airway. | Count of Units | surgical procedure | surgical procedure |
|
|
| History of difficult intubation within past 5 years | Count of Units | surgical procedure | surgical procedure |
|
|
| OG001 |
| 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); |
|
|
|
| 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. | Posted | Count of Units | Surgical procedures | From the start time of intubation to time of the end of surgery. | Surgical procedures | Surgical procedures |
|
|
|
|
| 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. | Posted | Count of Units | Surgical procedures | From the start time of intubation to time of the end of surgery. | Surgical procedures | Surgical procedures |
|
|
|
|
| Other Pre-specified | Maximum Mean Arterial Pressure | Maximum mean arterial pressure (MAP) in the five minutes after intubation | N = 64 surgical procedures had missing MAP in the Videolaryngoscopy group; N = 39 procedures had missing MAP in the Direct laryngoscopy group. | Posted | Mean | Standard Deviation | mmHg | In five minutes after intubation. | Surgical procedures | Surgical procedures |
|
|
|
|
| Other Pre-specified | Maximum Heart Rate (HR) | Maximum heart rate in the five minutes after intubation | N = 26 procedures had missing HR in Videolaryngoscopy group; N = 17 procedures had missing HR in Direct laryngoscopy group. | Posted | Mean | Standard Deviation | beats/min | In five minutes after intubation | Surgical procedures | Surgical procedures |
|
|
|
|
| 0 |
| 4,413 |
| 0 |
| 4,413 |
| 0 |
| 4,413 |
| EG001 | 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); | 0 | 4,016 | 0 | 4,016 | 0 | 4,016 |
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| Title | Measurements |
|---|---|
|
| Other |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Other |
|
| Thoracic |
|
| Title | Measurements |
|---|---|
|
| 3 (Severe systemic illness) |
|
| 4 (Life-threatening systemic illness) |
|
| 5 (Not expected to survive without the operation) |
|
| Title | Measurements |
|---|---|
|
| Fellow |
|
| SRNA |
|
| Attending anesthesiologist |
|
| Medical student |
|
|
| III (Soft palate, base of uvula visible) |
|
| IV (Only hard palate visible) |
|
| Missing |
|