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RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

Not Applicable
Completed
Conditions
Intubation; Difficult
Interventions
Device: Fiberoptic Bronchoscope
Device: RIFL (Rigid and Flexing Laryngoscope)
Registration Number
NCT01965938
Lead Sponsor
Vanderbilt University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Fiberoptic BronchoscopeFiberoptic BronchoscopePatients 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.
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.
Primary Outcome Measures
NameTimeMethod
Time Until Proper Endotracheal Tube Placementusually <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 Outcome Measures
NameTimeMethod
Alternate Device Used<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

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
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

Trial Locations

Locations (1)

Vanderbilt University Medical Center

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Nashville, Tennessee, United States

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