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OpenTrials
Completed

NCT Number: NCT01965938

RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

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.

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Key information

Conditions

Intubation; Difficult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Video RIFL RIgid Flexible Laryngoscope, AI Medical Devices, Inc

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.

Primary outcomes

  1. Time Until Proper Endotracheal Tube Placement

    Time frame: usually <100 seconds

    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.

Secondary outcomes

  1. Number of Participants With Successful Intubation

    Time frame: <100 seconds

    Successful intubation defined as confirming tube placement by the presence of etCO2;

  2. Number of Attempts Performed During Airway Management

    Time frame: <100 seconds

  3. Grade of Glottic View

    Time frame: <100 seconds

    According to McCormack and Lehane

  4. Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist

    Time frame: <100 seconds

    Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc

  5. Lowest Pulse Oximetry Saturation Value Reading During Intubation

    Time frame: <100 seconds

    Lowest pulse oximetry saturation value reading collected from any participant during intubation

  6. Alternate Device Used

    Time frame: <100 seconds

Other outcomes

  1. Oropharyngeal Injuries

    Time frame: 24 hours

    Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 18, 2013
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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