Clinical Trials Directory

Trials / Completed

CompletedNCT01965938

RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
41 (actual)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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 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.

Timeline

Start date
2012-09-01
Primary completion
2013-07-01
Completion
2013-07-01
First posted
2013-10-18
Last updated
2017-01-05
Results posted
2017-01-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01965938. Inclusion in this directory is not an endorsement.