Intubation; DifficultBFONCT02769819
Identification of Morphological Characteristics to Predict Difficult Endotracheal Intubation Using a Flexible Fiberscope
A study testing Flexible fiberscope in people with Intubation; Difficult, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This study is designed to identify patients' features predictive of difficult endotracheal intubation using a flexible fiberscope. 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?
- Flexible fiberscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to 12 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18 and older
- Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation
Who cannot join
- Induction planned without neuromuscular blocking agents
- Need for a rapid sequence induction
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
This study is designed to identify patients' features predictive of difficult endotracheal intubation using a flexible fiberscope.
Read the detailed description
Endotracheal intubation is an important act in the practice of anesthesiology. Direct laryngoscopy is the most commonly used technique to accomplish this task. Airway characteristics predicting difficult intubation with direct laryngoscopy are well defined. Physical findings, such as Mallampati classification or measurements of the thyromental distance, mouth opening, and neck extension have been validated to help anticipate difficult situations with the direct laryngoscope. When direct laryngoscopy is difficult, early conversion to an alternative technique reduces the risk of airway compromise and associated morbidity.
Many alternative intubation devices are now available, and part of the anesthesiologist's task is to select the alternative approach best suited to each patient's specific features. Despite its use for both elective and unexpectedly difficult intubation, predictive criteria for successful airway management with the flexible fiberscope have not been developed.
The purpose of this study is to identify patient morphometric or morphological characteristics, if any, that could predict difficult intubation when using the flexible fiberscope for perioperative tracheal intubation in an elective surgical population.
- Conditions
- Intubation; Difficult
- Being tested
- Flexible fiberscope
- Keywords
- Flexible fiberscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible fiberscopeDevice
- Characteristics of patients will be assessed before induction of general anesthesia
- Glottic visualization will be evaluated by direct laryngoscopy.
- The endotracheal tube will be loaded onto the scope after silicon spray lubrication
- Intubation will be performed with the flexible fiberscope with the patient in supine position with head and neck in neutral position
- With the tip of the fiberscope in satisfactory position, the endotracheal tube will be advanced into the trachea. The scope will then be removed.
- Accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation.
| Study group | Role | What they receive |
|---|---|---|
| Intubation with a flexible fiberscope | Experimental | Following induction of general anesthesia and administration of a neuromuscular blocking agent, intubation will be performed using a flexible fiberscope. Receives: Device: Flexible fiberscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphologic and morphometric predictors of difficult intubation with the flexible fiberscope.
This study will correlate patients' morphometric and morphologic characteristics with the number of attempts and time needed for intubation using a flexible fiberscope.
Measured: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Secondary outcomes (3)
Time to successful intubation
Measured: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Number of attempts to successful intubation
Measured: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Score on the Intubation Difficulty Scale
To calculate the Intubation Difficulty Scale the following variables will be collected: number of attempts, number of operators, necessity to use an alternative intubation technique, glottic visualization and effort needed to obtain optimal view of the glottis, necessity of external laryngeal pressure and vocal cords position during intubation.
Measured: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startOct 2016
- Primary completion12 Sep 2017
- Study completion12 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan R Williams, MD, PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769819
- Sponsor's protocol ID
- 16.051
- Acronym
- BFO
- Status last verified
- Oct 2017
- First submitted
- 10 May 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Toure T, Williams SR, Kerouch M, Ruel M. Patient factors associated with difficult flexible bronchoscopic intubation under general anesthesia: a prospective observational study. Can J Anaesth. 2020 Jun;67(6):706-714. doi: 10.1007/s12630-020-01568-w. Epub 2020 Jan 17.
PubMed 31953669
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Morphological Characteristics to Predict Difficult Endotracheal Intubation Using a Flexible Fiberscope
- ClinicalTrials.gov ID
- NCT02769819
- Acronym / sponsor ID
- BFO / 16.051
- Conditions
- Intubation; Difficult
- Keywords
- Flexible fiberscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to identify patients' features predictive of difficult endotracheal intubation using a flexible fiberscope.
Detailed description
Endotracheal intubation is an important act in the practice of anesthesiology. Direct laryngoscopy is the most commonly used technique to accomplish this task. Airway characteristics predicting difficult intubation with direct laryngoscopy are well defined. Physical findings, such as Mallampati classification or measurements of the thyromental distance, mouth opening, and neck extension have been validated to help anticipate difficult situations with the direct laryngoscope. When direct laryngoscopy is difficult, early conversion to an alternative technique reduces the risk of airway compromise and associated morbidity.
Many alternative intubation devices are now available, and part of the anesthesiologist's task is to select the alternative approach best suited to each patient's specific features. Despite its use for both elective and unexpectedly difficult intubation, predictive criteria for successful airway management with the flexible fiberscope have not been developed.
The purpose of this study is to identify patient morphometric or morphological characteristics, if any, that could predict difficult intubation when using the flexible fiberscope for perioperative tracheal intubation in an elective surgical population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubation with a flexible fiberscope | Experimental | Device: Flexible fiberscopeFollowing induction of general anesthesia and administration of a neuromuscular blocking agent, intubation will be performed using a flexible fiberscope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and older
- Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation
Key exclusion criteria (2 listed)
- Induction planned without neuromuscular blocking agents
- Need for a rapid sequence induction
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 |
|---|---|---|
| Flexible fiberscope* Characteristics of patients will be assessed before induction of general anesthesia * Glottic visualization will be evaluated by direct laryngoscopy. * The endotracheal tube will be loaded onto the scope after silicon spray lubrication * Intubation will be performed with the flexible fiberscope with the patient in supine position with head and neck in neutral position * With the tip of the fiberscope in satisfactory position, the endotracheal tube will be advanced into the trachea. The scope will then be removed. * Accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation. | Device | Intubation with a flexible fiberscope |
Primary outcome
Morphologic and morphometric predictors of difficult intubation with the flexible fiberscope.
Time frame: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
This study will correlate patients' morphometric and morphologic characteristics with the number of attempts and time needed for intubation using a flexible fiberscope.
3 secondary outcomes
Time to successful intubation
Time frame: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Number of attempts to successful intubation
Time frame: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Score on the Intubation Difficulty Scale
Time frame: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Derived from this study: PubMed 31953669Toure T, Williams SR, Kerouch M, Ruel M. Patient factors associated with difficult flexible bronchoscopic intubation under general anesthesia: a prospective observational study. Can J Anaesth. 2020 Jun;67(6):706-714. doi: 10.1007/s12630-020-01568-w. Epub 2020 Jan 17.
- 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.
Stephan R Williams, MD, PhD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible fiberscope in people with Intubation; Difficult, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 2 inclusion and 2 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 9 Oct 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Morphologic and morphometric predictors of difficult intubation with the flexible fiberscope. (time frame: Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769819, which also lists 1 linked publication.
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 9 Oct 2017.