Intubation; DifficultNCT01965938
RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope
A study testing RIFL (Rigid and Flexing Laryngoscope) and Fiberoptic Bronchoscope in people with Intubation; Difficult, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- RIFL (Rigid and Flexing Laryngoscope) and Fiberoptic Bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who necessitate an awake fiberoptic intubation or a rapid sequence intubation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope: A Comparison of the Ease of Use During Intubation on Difficult Airways
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.
Read the 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
- Intubation; Difficult
- Being tested
- RIFL (Rigid and Flexing Laryngoscope), Fiberoptic Bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIFL (Rigid and Flexing Laryngoscope)Device
Also called Video RIFL RIgid Flexible Laryngoscope, AI Medical Devices, Inc
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 BronchoscopeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Fiberoptic Bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: usually <100 seconds
Secondary outcomes (6)
Number of Participants With Successful Intubation
Successful intubation defined as confirming tube placement by the presence of etCO2;
Measured: <100 seconds
Number of Attempts Performed During Airway Management
Measured: <100 seconds
Grade of Glottic View
According to McCormack and Lehane
Measured: <100 seconds
Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist
Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc
Measured: <100 seconds
Lowest Pulse Oximetry Saturation Value Reading During Intubation
Lowest pulse oximetry saturation value reading collected from any participant during intubation
Measured: <100 seconds
Alternate Device Used
Measured: <100 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bret Alvis, Vanderbilt University
- Investigators
- Bret Alvis, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965938
- Sponsor's protocol ID
- 121408
- Status last verified
- Oct 2016
- First submitted
- 16 Oct 2013
- Last updated
- 5 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope: A Comparison of the Ease of Use During Intubation on Difficult Airways
- ClinicalTrials.gov ID
- NCT01965938
- Acronym / sponsor ID
- 121408
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Posted 5 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope) | Active comparator | 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 | Other | Device: Fiberoptic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with an oropharyngeal score of 3 or 4
- patients whose body mass index calculates greater to or equal to 35
Key exclusion criteria (1 listed)
- Patients who necessitate an awake fiberoptic intubation or a rapid sequence intubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIFL (Rigid and Flexing Laryngoscope)Also: Video RIFL RIgid Flexible Laryngoscope, AI Medical Devices, IncPatients 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 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. | Device | Fiberoptic Bronchoscope |
Primary outcome
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.
6 secondary outcomes
Number of Participants With Successful Intubation
Time frame: <100 seconds
Number of Attempts Performed During Airway Management
Time frame: <100 seconds
Grade of Glottic View
Time frame: <100 seconds
Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist
Time frame: <100 seconds
Lowest Pulse Oximetry Saturation Value Reading During Intubation
Time frame: <100 seconds
Alternate Device Used
Time frame: <100 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bret Alvis, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIFL (Rigid and Flexing Laryngoscope) and Fiberoptic Bronchoscope in people with Intubation; Difficult, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Until Proper Endotracheal Tube Placement (time frame: usually <100 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.