RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope: A Comparison of the Ease of Use During Intubation on Difficult Airways

Conditions
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Intubation; Difficult

Intervention / Treatment
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* Device: RIFL (Rigid and Flexing Laryngoscope)
* Device: Fiberoptic Bronchoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with known or suspected difficult airways defined as: patients with an oropharyngeal score of 3 or 4 patients whose body mass index calculates greater to or equal to 35 Exclusion Criteria: Patients who necessitate an awake fiberoptic intubation or a rapid sequence intubation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIFL (Rigid and Flexing Laryngoscope)<br>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. | Device: RIFL (Rigid and Flexing Laryngoscope)<br>* 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.<br>* Other names: AI Medical Devices, Inc;|
| Other: Fiberoptic Bronchoscope<br>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. | Device: Fiberoptic Bronchoscope<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | <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 |