RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

Intubation; Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965938
• Other study ID #: 121408
• Status: Completed
• Phase: N/A
• First received: October 16, 2013
• Last updated: December 10, 2014
• Start date: September 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Device:
• 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.
• Fiberoptic Bronchoscope
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Notation of any trauma to lips, teeth, soft tissue, etc.	<100 seconds	No
Primary	Time until proper endotracheal tube placement	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;	<100 seconds	No
Secondary	Success of first attempt of fiberoptic intubation	Successful intubation defined as confirming tube placement by the presence of etCO2;	<100 seconds	No
Secondary	Number of attempts performed during airway management and alternate device used, if necessary		<100 seconds	No
Secondary	Grade of glottic view	According to McCormack and Lehane	<100 seconds	No
Secondary	Assistance maneuvers, if any, provided by the attending anesthesiologist	Examples include jaw lift, tongue protrusion, laryngeal pressure, etc	<100 seconds	No
Secondary	Time to reach 90% pulse oximetry saturation value and lowest pulse oximetry saturation value reading during intubation		<100 seconds	No