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We will conduct a randomized trial comparing the success rate and time to intubation using the RIFL vs. the fiberoptic bronchoscope, as the latter is commonly held to be the gold standard of difficult airway devices. Specifically, we wish to compare the of intubation between the two devices in patients with potentially difficult airways as defined by an oropharyngeal class 3-4, BMI greater than 35, or in patients with a history of difficult intubation using direct laryngoscopy.
Patients who require general anesthesia with endotracheal intubation will be identified the night prior to their surgery based upon the examination documented in their preoperative history and physical. If their body mass index achieves a calculated score of 35 or greater or they have an oropharyngeal class 4 airway then they will qualify to participate.
After written informed consent is obtained, The intubation method would be randomized as one of two groups: intubation via use of the fiberoptic bronchoscope or the RIFL. The intubation attempt will be terminated if the SpO2 <90, HR<50, there is traumatic injury, or time > 100sec. If terminated, the patient will be mask ventilated and the attending anesthesiologist would determine the subsequent technique that will be used for airway management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Active Comparator | Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
|
| Fiberoptic Bronchoscope | Other | Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Device | Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Until Proper Endotracheal Tube Placement | Time (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation. | usually <100 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Intubation | Successful intubation defined as confirming tube placement by the presence of etCO2; | <100 seconds |
| Number of Attempts Performed During Airway Management |
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal Injuries | Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc. | 24 hours |
Inclusion Criteria:
Patients with known or suspected difficult airways defined as:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bret Alvis, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RIFL (Rigid and Flexing Laryngoscope) | RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
| FG001 | Fiberoptic Bronchoscope | Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | RIFL (Rigid and Flexing Laryngoscope) | RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
| BG001 |
| 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 | Time Until Proper Endotracheal Tube Placement | Time (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation. | Posted | Median | Inter-Quartile Range | seconds | usually <100 seconds |
|
During hospital stay (approximately 1-4 days)
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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 | RIFL (Rigid and Flexing Laryngoscope) | RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oropharyngeal injuries | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bret Alvis, MD | Vanderbilt University School of Medicine | 615-343-6268 | bret.d.alvis@vanderbilt.edu |
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|
| Fiberoptic Bronchoscope | Device | Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
|
| <100 seconds |
| Grade of Glottic View | According to McCormack and Lehane | <100 seconds |
| Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist | Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc | <100 seconds |
| Lowest Pulse Oximetry Saturation Value Reading During Intubation | Lowest pulse oximetry saturation value reading collected from any participant during intubation | <100 seconds |
| Alternate Device Used | <100 seconds |
| Fiberoptic Bronchoscope |
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Mallampati Class (N) | Mallampati Class Class I: Soft palate, fauces, uvula, pillars visible Class II: Soft palate, fauces, uvula visible Class III: Soft palate, base of uvula visible Class IV: Soft palate not visible at all A high Mallampati score (class 3 or 4) is associated with more difficult intubation | Number | participants |
|
| Anticipated Difficult airway | Anticipated difficult airway was defined as patients who met one or more of the following criteria: past history of documented difficult intubation, Mallampati Score ≥3, and a body mass index (BMI)≥35. | Number | participants |
|
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. |
|
|
| Secondary | Number of Participants With Successful Intubation | Successful intubation defined as confirming tube placement by the presence of etCO2; | Posted | Number | participants | <100 seconds |
|
|
|
| Secondary | Number of Attempts Performed During Airway Management | Posted | Mean | Standard Deviation | number attempts | <100 seconds |
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| Secondary | Grade of Glottic View | According to McCormack and Lehane | data was not collected | Posted | <100 seconds |
|
|
| Secondary | Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist | Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc | Posted | Number | participants | <100 seconds |
|
|
|
| Secondary | Lowest Pulse Oximetry Saturation Value Reading During Intubation | Lowest pulse oximetry saturation value reading collected from any participant during intubation | Posted | Number | percentage of saturated hemoglobin | <100 seconds |
|
|
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| Other Pre-specified | Oropharyngeal Injuries | Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc. | Posted | Number | participants | 24 hours |
|
|
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| Secondary | Alternate Device Used | Posted | Number | number times an alternate device used | <100 seconds |
|
|
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| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Fiberoptic Bronchoscope | Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed. | 0 | 20 | 3 | 20 |
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