Intubation; Difficult
Conditions
Brief summary
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
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.
Interventions
DEVICERIFL (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.
DEVICEFiberoptic 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.
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Until Proper Endotracheal Tube Placement | usually <100 seconds | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Intubation | <100 seconds | Successful intubation defined as confirming tube placement by the presence of etCO2; |
| Number of Attempts Performed During Airway Management | <100 seconds | — |
| Grade of Glottic View | <100 seconds | According to McCormack and Lehane |
| Lowest Pulse Oximetry Saturation Value Reading During Intubation | <100 seconds | Lowest pulse oximetry saturation value reading collected from any participant during intubation |
| Alternate Device Used | <100 seconds | — |
| Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist | <100 seconds | Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Injuries | 24 hours | Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | RIFL (Rigid and Flexing Laryngoscope) | Fiberoptic Bronchoscope | Total |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 15 | 49 years STANDARD_DEVIATION 12 | 49.5 years STANDARD_DEVIATION 14 |
| Anticipated Difficult airway No | 11 participants | 14 participants | 25 participants |
| Anticipated Difficult airway Yes | 9 participants | 6 participants | 15 participants |
| Gender Female | 10 Participants | 13 Participants | 23 Participants |
| Gender Male | 10 Participants | 7 Participants | 17 Participants |
| Mallampati Class (N) Class 1 | 3 participants | 1 participants | 4 participants |
| Mallampati Class (N) Class 2 | 2 participants | 3 participants | 5 participants |
| Mallampati Class (N) Class 3 | 6 participants | 7 participants | 13 participants |
| Mallampati Class (N) Class 4 | 9 participants | 9 participants | 18 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 20 | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: usually <100 seconds
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Time Until Proper Endotracheal Tube Placement | 49 seconds |
| Fiberoptic Bronchoscope | Time Until Proper Endotracheal Tube Placement | 64 seconds |
Secondary
Alternate Device Used
Time frame: <100 seconds
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Alternate Device Used | 0 number times an alternate device used |
| Fiberoptic Bronchoscope | Alternate Device Used | 0 number times an alternate device used |
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
Time frame: <100 seconds
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist | 2 participants |
| Fiberoptic Bronchoscope | Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist | 16 participants |
Secondary
Grade of Glottic View
According to McCormack and Lehane
Time frame: <100 seconds
Population: data was not collected
Secondary
Lowest Pulse Oximetry Saturation Value Reading During Intubation
Lowest pulse oximetry saturation value reading collected from any participant during intubation
Time frame: <100 seconds
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Lowest Pulse Oximetry Saturation Value Reading During Intubation | 100 percentage of saturated hemoglobin |
| Fiberoptic Bronchoscope | Lowest Pulse Oximetry Saturation Value Reading During Intubation | 100 percentage of saturated hemoglobin |
Secondary
Number of Attempts Performed During Airway Management
Time frame: <100 seconds
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Number of Attempts Performed During Airway Management | 1.1 number attempts | Standard Deviation 0.3 |
| Fiberoptic Bronchoscope | Number of Attempts Performed During Airway Management | 1.2 number attempts | Standard Deviation 0.5 |
Secondary
Number of Participants With Successful Intubation
Successful intubation defined as confirming tube placement by the presence of etCO2;
Time frame: <100 seconds
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Number of Participants With Successful Intubation | 20 participants |
| Fiberoptic Bronchoscope | Number of Participants With Successful Intubation | 20 participants |
Other Pre-specified
Oropharyngeal Injuries
Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Oropharyngeal Injuries | 2 participants |
| Fiberoptic Bronchoscope | Oropharyngeal Injuries | 3 participants |