RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

NCT01965938 | Completed Results DMC

• 1 other identifier: 121408
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

• 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 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.

  usually <100 seconds

Secondary Outcomes (6)

• Number of Participants With Successful Intubation

  <100 seconds

• Number of Attempts Performed During Airway Management

  <100 seconds

• Grade of Glottic View

  <100 seconds

• Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist

  <100 seconds

• Lowest Pulse Oximetry Saturation Value Reading During Intubation

  <100 seconds

Other Outcomes (1)

• Oropharyngeal Injuries

  24 hours

Study Arms (2)

RIFL (Rigid and Flexing Laryngoscope)

ACTIVE COMPARATOR

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.

Device: RIFL (Rigid and Flexing Laryngoscope)

Fiberoptic Bronchoscope

OTHER

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.

Device: Fiberoptic Bronchoscope

Interventions

RIFL (Rigid and Flexing Laryngoscope) DEVICE

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.

Also known as: Video RIFL RIgid Flexible Laryngoscope, AI Medical Devices, Inc

RIFL (Rigid and Flexing Laryngoscope)

Fiberoptic Bronchoscope DEVICE

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.

Fiberoptic Bronchoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who necessitate an awake fiberoptic intubation or a rapid sequence intubation.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Results Point of Contact

• Title: Dr. Bret Alvis, MD
• Organization: Vanderbilt University School of Medicine

bret.d.alvis@vanderbilt.edu

615-343-6268

Study Officials

• Bret Alvis, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 18, 2013
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 5, 2017
• Results First Posted: January 5, 2017

Record last verified: 2016-10

Locations

US (1)