An interventional study of RIFL (Rigid and Flexing Laryngoscope) and Fiberoptic Bronchoscope in Intubation; Difficult, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-05.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Health services research
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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Patients with known or suspected difficult airways defined as:
Exclusion Criteria:
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)
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
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.
Also known as: Video RIFL RIgid Flexible Laryngoscope, AI Medical Devices, Inc
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.
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.
Time frame: usually <100 seconds
Number of Participants With Successful Intubation
Successful intubation defined as confirming tube placement by the presence of etCO2;
Time frame: <100 seconds
Number of Attempts Performed During Airway Management
Time frame: <100 seconds
Grade of Glottic View
According to McCormack and Lehane
Time frame: <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
Time frame: <100 seconds
Lowest Pulse Oximetry Saturation Value Reading During Intubation
Lowest pulse oximetry saturation value reading collected from any participant during intubation
Time frame: <100 seconds
Alternate Device Used
Time frame: <100 seconds
Oropharyngeal Injuries
Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc.
Time frame: 24 hours
| Milestone | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope |
|---|---|---|
| Started | 21 | 20 |
| Completed | 20 | 20 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| seconds | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope |
|---|---|---|
| Time Until Proper Endotracheal Tube Placement | 49 (24 to 73) | 64 (40 to 120) |
Successful intubation defined as confirming tube placement by the presence of etCO2;
| participants | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope |
|---|---|---|
| Number of Participants With Successful Intubation | 20 | 20 |
| number attempts | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope |
|---|---|---|
| Number of Attempts Performed During Airway Management | 1.1 ± 0.3 | 1.2 ± 0.5 |
According to McCormack and Lehane
No measurements were reported for this outcome.
Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc
| participants | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope |
|---|---|---|
| Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist | 2 | 16 |
Lowest pulse oximetry saturation value reading collected from any participant during intubation
| percentage of saturated hemoglobin | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope |
|---|---|---|
| Lowest Pulse Oximetry Saturation Value Reading During Intubation | 100 | 100 |
Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc.
| participants | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope |
|---|---|---|
| Oropharyngeal Injuries | 2 | 3 |
| number times an alternate device used | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope |
|---|---|---|
| Alternate Device Used | 0 | 0 |
Collected over During hospital stay (approximately 1-4 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | — | 0/20 (0%) | 2/20 (10%) |
| Fiberoptic Bronchoscope | — | 0/20 (0%) | 3/20 (15%) |
| Event | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope |
|---|---|---|
| Oropharyngeal injuriesInjury, poisoning and procedural complications | 2/20 | 3/20 |
| Age, Continuous(years) | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope | Total |
|---|---|---|---|
| Mean | 50 ± 15 | 49 ± 12 | 49.5 ± 14 |
| Gender(Participants) | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope | Total |
|---|---|---|---|
| Female | 10 | 13 | 23 |
| Male | 10 | 7 | 17 |
| Mallampati Class (N)(participants) | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope | Total |
|---|---|---|---|
| Class 1 | 3 | 1 | 4 |
| Class 2 | 2 | 3 | 5 |
| Class 3 | 6 | 7 | 13 |
| Class 4 | 9 | 9 | 18 |
| Anticipated Difficult airway(participants) | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope | Total |
|---|---|---|---|
| Yes | 9 | 6 | 15 |
| No | 11 | 14 | 25 |
Plan to share: Undecided
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