Endotracheal IntubationNCT01975987
Characteristics to Predict Successful Intubation With the Bonfils Fiberscope
A study testing Bonfils fiberscope in people with Endotracheal Intubation, 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 successful intubation using the Bonfils fiberscope. Our hypothesis is that some patients' characteristics are predictors of successful intubation with the Bonfils fiberscope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Bonfils fiberscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jul 2014
- 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
Official title: Identification of Morphological Characteristics to Predict Successful Intubation With the Bonfils Fiberscope
This study is designed to identify patients' features predictive of successful intubation using the Bonfils fiberscope.
Our hypothesis is that some patients' characteristics are predictors of successful intubation with the Bonfils 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. When direct laryngoscopy is strenuous, early conversion to an alternative technique might reduce the risk of airway compromise and associated morbidity.
Many 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 Bonfils fiberscope have not been proposed.
The purpose of this study is to identify patients' features, if any, that could predict successful intubation when using the Bonfils fiberscope for perioperative orotracheal intubation in an elective surgical population.
- Conditions
- Endotracheal Intubation
- Being tested
- Bonfils fiberscope
- Keywords
- Intubation, Bonfils fiberscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bonfils fiberscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Intubation with the Bonfils fiberscope | Experimental | * 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
* Intubation will be performed with the Bonfils fiberscope with the patient in supine position with head and neck in neutral position
* Bonfils fiberscope will be inserted from the right side of the patient's mouth, alongside the molars and advanced underneath the epiglottis. With the tip of the Bonfils in satisfactory position, the endotracheal tube will be advanced into the trachea using gentle rotary motions. The scope will then be removed.
* Accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation. Receives: Device: Bonfils fiberscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphologic and morphometric predictors of successful tracheal intubation with the Bonfils fiberscope
This study will correlate patients' morphometric and morphologic characteristics with the number of attempts and time needed for intubation using the Bonfils 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 Score 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 posted5 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Robitaille, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975987
- Sponsor's protocol ID
- 13.182
- Status last verified
- Jul 2014
- First submitted
- 22 Oct 2013
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Morphological Characteristics to Predict Successful Intubation With the Bonfils Fiberscope
- ClinicalTrials.gov ID
- NCT01975987
- Acronym / sponsor ID
- 13.182
- Conditions
- Endotracheal Intubation
- Keywords
- Intubation, Bonfils fiberscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Nov 2013 (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 successful intubation using the Bonfils fiberscope.
Our hypothesis is that some patients' characteristics are predictors of successful intubation with the Bonfils 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. When direct laryngoscopy is strenuous, early conversion to an alternative technique might reduce the risk of airway compromise and associated morbidity.
Many 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 Bonfils fiberscope have not been proposed.
The purpose of this study is to identify patients' features, if any, that could predict successful intubation when using the Bonfils fiberscope for perioperative orotracheal intubation in an elective surgical population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubation with the Bonfils fiberscope | Experimental | Device: Bonfils 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 * Intubation will be performed with the Bonfils fiberscope with the patient in supine position with head and neck in neutral position * Bonfils fiberscope will be inserted from the right side of the patient's mouth, alongside the molars and advanced underneath the epiglottis. With the tip of the Bonfils in satisfactory position, the endotracheal tube will be advanced into the trachea using gentle rotary motions. The scope will then be removed. * Accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation. |
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 |
|---|---|---|
| Bonfils fiberscope | Device | Intubation with the Bonfils fiberscope |
Primary outcome
Morphologic and morphometric predictors of successful tracheal intubation with the Bonfils 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 the Bonfils 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 18 Jul 2014.
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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.
Arnaud Robitaille, MD, FRCPC 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 Bonfils fiberscope in people with Endotracheal Intubation, 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 18 Jul 2014. 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 successful tracheal intubation with the Bonfils 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?
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 18 Jul 2014.