Clinical Trial: RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Vanderbilt University

Current Primary Outcome: Time Until Proper Endotracheal Tube Placement [ Time Frame: 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.


Original Primary Outcome: Time Until Proper Endotracheal Tube Placement [ Time Frame: <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 etCO2;


Current Secondary Outcome:

  • Number of Participants With Successful Intubation [ Time Frame: <100 seconds ]
    Successful intubation defined as confirming tube placement by the presence of etCO2;
  • Number of Attempts Performed During Airway Management [ Time Frame: <100 seconds ]
  • Grade of Glottic View [ Time Frame: <100 seconds ]
    According to McCormack and Lehane
  • Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist [ Time Frame: <100 seconds ]
    Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc
  • Lowest Pulse Oximetry Saturation Value Reading During Intubation [ Time Frame: <100 seconds ]
    Lowest pulse oximetry saturation value reading collected from any participant during intubation
  • Alternate Device Used [ Time Frame: <100 seconds ]


Original Secondary Outcome:

  • Success of first attempt of fiberoptic intubation [ Time Frame: <100 seconds ]
    Successful intubation defined as confirming tube placement by the presence of etCO2;
  • Number of attempts performed during airway management and alternate device used, if necessary [ Time Frame: <100 seconds ]
  • Grade of Glottic View [ Time Frame: <100 seconds ]
    According to McCormack and Lehane
  • Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist [ Time Frame: <100 seconds ]
    Examples include jaw lift, tongue protrusion, laryngeal pressure, etc
  • Time to reach 90% pulse oximetry saturation value and lowest pulse oximetry saturation value reading during intubation [ Time Frame: <100 seconds ]


Information By: Vanderbilt University

Dates:
Date Received: October 16, 2013
Date Started: September 2012
Date Completion:
Last Updated: November 5, 2016
Last Verified: October 2016