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The purpose of this research is to learn about the difference in the endotracheal intubation condition (ease of using a device to view vocal cords, position of vocal cords, and patient's reaction to endotracheal tube insertion) and determining the appropriate time to perform the intubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intubation at TOFC=1 | Experimental | Subjects scheduled for an elective surgical procedure will have endotracheal intubation performed when muscles are almost relaxed and monitoring shows only a single count of muscle twitch (in response to a monitor that assesses muscle relaxation) |
|
| Intubation 2 minutes after rocuronium administration | Active Comparator | Subjects scheduled for an elective surgical procedure will have endotracheal intubation performed 2 minutes after the anesthesia provider gives muscle relaxing medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal Intubation at TOFC=1 | Procedure | Intubation using a video laryngoscopy will be performed after train-of-four (TOFC) stimulation indicates neuromuscular blockade |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Optimal Intubating Conditions | The number of subjects who had optimal intubating conditions (total composite score of 3) will be evaluated by the healthcare providers using a scale that includes 3 variables (ease of laryngoscopy, vocal cord position, and reaction to tracheal tube insertion) with 3 response options per each evaluation. The composite score (1-3) will be used, with the lowest total score of 3 correlating with optimal intubating conditions and the highest score of 9 representing the worse possible intubating conditions. | Approximately 15 minutes after intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Ross Renew, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32223 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intubation at TOFC=1 | Subjects scheduled for an elective surgical procedure had endotracheal intubation performed when muscles were almost relaxed and monitoring showed only a single count of muscle twitch (in response to a monitor that assessed muscle relaxation) Endotracheal Intubation at TOFC=1: Intubation using a video laryngoscopy was performed after train-of-four (TOFC) stimulation indicated neuromuscular blockade |
| FG001 | Intubation 2 Minutes After Rocuronium Administration | Subjects scheduled for an elective surgical procedure had endotracheal intubation performed 2 minutes after the anesthesia provider gave muscle relaxing medication Endotracheal Intubation 2 minutes after rocuronium administration: Intubation using a video laryngoscopy was performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intubation at TOFC=1 | Subjects scheduled for an elective surgical procedure had endotracheal intubation performed when muscles were almost relaxed and monitoring showed only a single count of muscle twitch (in response to a monitor that assessed muscle relaxation) Endotracheal Intubation at TOFC=1: Intubation using a video laryngoscopy was performed after train-of-four (TOFC) stimulation indicated neuromuscular blockade |
| 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 | Number of Subjects With Optimal Intubating Conditions | The number of subjects who had optimal intubating conditions (total composite score of 3) will be evaluated by the healthcare providers using a scale that includes 3 variables (ease of laryngoscopy, vocal cord position, and reaction to tracheal tube insertion) with 3 response options per each evaluation. The composite score (1-3) will be used, with the lowest total score of 3 correlating with optimal intubating conditions and the highest score of 9 representing the worse possible intubating conditions. | Posted | Count of Participants | Participants | Approximately 15 minutes after intubation |
|
Adverse events were collected from the time of informed consent through study completion, approximately 15 minutes.
Adverse events were collected through specific questioning and examination.
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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 | Intubation at TOFC=1 | Subjects scheduled for an elective surgical procedure had endotracheal intubation performed when muscles were almost relaxed and monitoring showed only a single count of muscle twitch (in response to a monitor that assessed muscle relaxation) Endotracheal Intubation at TOFC=1: Intubation using a video laryngoscopy was performed after train-of-four (TOFC) stimulation indicated neuromuscular blockade |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Ross Renew, M.D. | Mayo Clinic | 904-956-3328 | renew.j@mayo.edu |
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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 | Nov 30, 2022 | Sep 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| Endotracheal Intubation 2 minutes after rocuronium administration | Procedure | Intubation using a video laryngoscopy will be performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine) |
|
| BG001 | Intubation 2 Minutes After Rocuronium Administration | Subjects scheduled for an elective surgical procedure had endotracheal intubation performed 2 minutes after the anesthesia provider gave muscle relaxing medication Endotracheal Intubation 2 minutes after rocuronium administration: Intubation using a video laryngoscopy was performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Intubation 2 Minutes After Rocuronium Administration | Subjects scheduled for an elective surgical procedure had endotracheal intubation performed 2 minutes after the anesthesia provider gave muscle relaxing medication Endotracheal Intubation 2 minutes after rocuronium administration: Intubation using a video laryngoscopy was performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine) |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | Intubation 2 Minutes After Rocuronium Administration | Subjects scheduled for an elective surgical procedure had endotracheal intubation performed 2 minutes after the anesthesia provider gave muscle relaxing medication Endotracheal Intubation 2 minutes after rocuronium administration: Intubation using a video laryngoscopy was performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine) | 0 | 85 | 0 | 85 | 0 | 85 |
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