Clinical trial NCT01965938: RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope
Official title: RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope: A Comparison of the Ease of Use During Intubation on Difficult Airways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time Until Proper Endotracheal Tube Placement
timeFrame: usually <100 seconds
Secondary outcomes:
measure: Number of Participants With Successful Intubation
timeFrame: <100 seconds
measure: Number of Attempts Performed During Airway Management
timeFrame: <100 seconds
measure: Grade of Glottic View
timeFrame: <100 seconds
measure: Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist
timeFrame: <100 seconds
measure: Lowest Pulse Oximetry Saturation Value Reading During Intubation
timeFrame: <100 seconds
measure: Alternate Device Used
timeFrame: <100 seconds
Other outcomes:
measure: Oropharyngeal Injuries
timeFrame: 24 hours
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Bret Alvis, M.D.
role: PRINCIPAL_INVESTIGATOR
References: