RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

Vanderbilt University

Status: Completed

Conditions: Intubation; Difficult

Treatments: Device: RIFL (Rigid and Flexing Laryngoscope); Device: Fiberoptic Bronchoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT01965938

121408

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

RIFL (Rigid and Flexing Laryngoscope)

Active Comparator group

Description:

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.

Treatment:

Device: RIFL (Rigid and Flexing Laryngoscope)

Fiberoptic Bronchoscope

Other group

Description:

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.

Treatment:

Device: Fiberoptic Bronchoscope