Difficult Airway IntubationNCT04532138
C-MAC Video Laryngoscope and VS-CMAC Fiberoptic Stylet for Awake Endoscopic Intubation in Predicted Difficult Airways
A study testing VS-CMAC Rigid Fiberoptic Stylet and C-MAC Video laryngoscope awake intubation in people with Difficult Airway Intubation, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
An Anticipated difficult tracheal intubation is recommended to be managed performing the so called "Awake tracheal endoscopic intubation" (ATI) with the maintenance of patient's spontaneous breathing after an adequate sedation and topical anesthesia of upper airways, providing supplemental oxygen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Airway Intubation
- What is being tested?
- VS-CMAC Rigid Fiberoptic Stylet and C-MAC Video laryngoscope awake intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 27 May 2020to 31 Dec 2020
- 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
- Schedule for elective surgery
- Detection of one or more of the following anthropometric criteria predictive of difficult intubation at the preoperative visit:
- Limitation of Cervical spine movements (traumatic or surgical arthrodesis)
- Mallampati score = 4
- Thyromental distance < 6 cm
- Interincisor distance < 3 cm
- Suspected difficult ventilation via face mask
- Previous history of difficult or failed intubation
Who cannot join
- age <18 years
- refusal of the patient
- urgent-emergency surgery
- patient's respiratory failure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Ospedali Riuniti Ancona - Università Politecnica delle Marche
Ancona, 60126
Abele Donati, MD, PhD, 00390715964643, a.donati@univpm.it
About this study
Official title: A Comparison Between C-MAC Video Laryngoscope an VS-CMAC Rigid Fiberoptic Stylet for Awake Endoscopic Intubation in Severe Predicted Difficult Airways: a Randomized Controlled Trial
An Anticipated difficult tracheal intubation is recommended to be managed performing the so called "Awake tracheal endoscopic intubation" (ATI) with the maintenance of patient's spontaneous breathing after an adequate sedation and topical anesthesia of upper airways, providing supplemental oxygen.
Initially only flexible bronchoscope was considered the device of choice (the gold standard) for ATI but in the last decade videolaryngoscopes with hyper-angulated blade have been demonstrated to be an efficacy technique.
Read more
Most recently, endoscopic rigid stylets such as Bonfils (Carl Storz™) and Sensacope (Acoutronic™) have been proposed as alternative techniques for ATI in the event of expected difficult tracheal intubation.
However, to date, no comparison studies have been carried out between these two kind of devices, alternative to flexible fiberscope, for ATI.
This is a clinical prospective randomized-controlled trial of non inferiority. The aim of this study is to compare the intubation success rate between two different devices (C-MAC Video Laryngoscope and VS-CMAC fiberoptic stylet) in patients with severe predicted difficult airways scheduled for elective surgery.
The primary endpoint is the comparison of success rate for the tracheal intubation, demonstrating the non inferiority of videostylet efficacy compared to the most consolidated technique based on videolaryngoscope.
Read the detailed description
This is a clinical prospective randomized-controlled trial of non inferiority, set in the operating theatre of a terziary university hospital in Ancona (Ospedali Riuniti Ancona).
The aim of this study is to compare the intubation success rate, defined as correct positioning of the tracheal tube inside the trachea, between Videostylet (VS-Carl Storz™) and videolaryngoscope with hyperangulated blade (C-MAC - Carl Storz™) in patients with severe predicted difficult airways scheduled for elective surgery.
All patients enrolled in the study, examined in the pre-operative visit, will be asked for informed consent and will undergo the same anesthetic protocol consisting in upper airways topicalization with Lidocaine and in smooth/moderate sedation (targeted on Ramsay sedation scale ≦ 3) by i.v. administration of midazolam 0,03 mg/kg and Fentanyl 100 mcg.
On arrival in the operating room, nasal oxygen (5 L/min) and routine monitoring of vital signs will be applied to all patients.
Heart rate and blood pressure will be recorded at the beginning of the procedure and every 3 minutes until the intubation will be performed, while arterial oxygen saturation is continuously recorded.
Patients enrolled will be randomly divided into 2 groups regarding to the device used for ATI:
- Videolaryngoscope (C-MAC) with Hyperangulated blade (D-blade)
- Videostylet (VS) Endotracheal tube will be 6,5-7,0 mm for female and 7,5-8,0 mm for male.
The following parameters will be registered:
- success rate of the procedure defined as correct positioning of the tracheal tube in the trachea confirmed both endoscopically and through the capnographic curve EtCO2
- average time of intubation procedure expressed in sec.
- operator's assessment of the subjective difficulty / handling of the device by means of a special analogue numerical scale
- assessment of the patient's tolerance to the procedure by means of a special analogue numerical scale checked after patient's awakening from anesthesia at the end of the intervention.
- occurrence of any complications or adverse event during the procedure (desaturation episodes, hemodynamic changes, oral-pharynx and larynx traumatism)
The primary endpoint is the comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of videostylet efficacy compare to the most consolidated technique based on videolaryngoscope.
The Null Hypothesis will be the following: The rate of Awake tracheal intubation failure with the VS video stylet is > 10% compared to video-laryngoscope.
Considering an unsuccessful intubation rate with the two devices at 10%, a sample of 34 patients (17 per group) is necessary to demonstrate with a power of 90% and alpha error of 0.05 that the rate of intubation failure using the videosylet (study method) does not exceed 10% of the rate of failed intubations through the use of the video laryngoscope (reference method).
Statistical analysis:
Normally distributed data will be expressed as mean ± standard deviation and 95% confidence interval, while data with non-normal distribution will be expressed as median and interquartile range.
The differences between means will be studied by parametric tests (e.g. Student's t) if the data are normally distributed and by nonparametric tests (e.g. Wilcoxon) if the distribution is not normal. The Kolmogorov-Smirnov test will be used to evaluate the normality of continuous variables.
The characteristics of the patients in the two groups will be compared using the Fisher test or the Chi-square test for the nominal variables and the Student t test or the Mann - Whitney U test for the continuous variables.
For each test p < 0.05 will be considered significant. For the primary endpoint: The difference in awake tracheal intubation success rate in the two groups will be assessed using Fisher's exact test. The non-inferiority of the use of the videostylet (VS) compared to the standard method (videolaryngoscope with D-Blade blade) will be confirmed if the difference, for 95% confidence interval, is less than the margin of non- inferiority established "a priori" as 10% after analysis of the literature (Alhomary et al. Anaesthesia 2018; 73: 1151-61)9 and according to clinical judgment.
For the secondary endpoints of the study a purely analytical-descriptive evaluation will be carried out.
- Conditions
- Difficult Airway Intubation
- Being tested
- VS-CMAC Rigid Fiberoptic Stylet, C-MAC Video laryngoscope awake intubation
- Keywords
- difficult airway, difficult intubation, awake endoscopic intubation, rigid fiberoptic stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS-CMAC Rigid Fiberoptic StyletDevice
patients with severe predicted difficult airways scheduled for elective surgery randomized to this groups will receive awake endoscopic intubation using VS-CMAC Rigid Fiberoptic Stylet.
C-MAC Video laryngoscope awake intubationDevice
Also called videolaryngoscope with hyperangulated blade
patients with severe predicted difficult airways scheduled for elective surgery randomized to this groups will receive awake endoscopic intubation using C-MAC Video Laryngoscope intubation.
| Study group | Role | What they receive |
|---|---|---|
| C-MAC Video laryngoscope awake intubation | Active comparator | In this group, patients with severe predicted difficult airways scheduled for elective surgery receive awake endoscopic intubation using Videolaryngoscope (C-MAC) with Hyperangulated blade (D-blade) Spontaneous breathing will be preserved in both groups of patients enrolled and the same protocol of sedation plus upper airways topical anesthesia will be applied. Receives: Device: C-MAC Video laryngoscope awake intubation |
| VS-CMAC Rigid Fiberoptic Stylet awake intubation | Experimental | In this group, patients with severe predicted difficult airways scheduled for elective surgery receive awake endoscopic intubation using VS-CMAC Rigid Fiberoptic Stylet.
Spontaneous breathing will be preserved in both groups of patients enrolled and the same protocol of sedation plus upper airways topical anesthesia will be applied. Receives: Device: VS-CMAC Rigid Fiberoptic Stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate of the rigid fiberoptic stylet to perform tracheal intubation in patients with anticipated difficult airways
The primary endopoint is the comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of videostylet efficacy compare to the most consolidated technique based on videolaryngoscope.
success rate of the procedure defined as correct positioning of the tracheal tube in the trachea confirmed both endoscopically and through the capnographic curve EtCO2
Measured: up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 minutes)
Secondary outcomes (5)
Numbers of intubation attempts
number of attempt to intubation. intubation will be considered complete when the ETT (endotracheal tube) will be positioned correctly into the trachea
Measured: up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 minutes)
average time of intubation procedure expressed in seconds
Time in minutes measured from device insertion into the patient's mouth until theETT will be positioned into the trachea
Measured: up to 15 minutes
Development of any complications
occurrence of any complications or adverse event during the procedure (desaturation episodes, hemodynamic changes, oral-pharynx and larynx traumatism)
Measured: up to 12 hours measured from the insertion of the device
The degree of patient's tolerability of the procedure (with a special Analogue Numerical Scale)
assessment of the patient's tolerance to the procedure by means of the Visual Numerical Scale checked after patient's awakening from anesthesia at the end of the intervention. The Numerical Analogue Scales is a measurement instrument for tolerance-intensity. it consists of a numerical line from 1 to 5 with the endpoints defining extreme limits that are 5="not possible to tolerate at all" and 1="easily tolerable". the patient is asked to mark his tolerance-level on the line between the two endpoints
Measured: up to 12 hours from the beginning of the procedure (from starting of awake intubation to complete recovering from general anaesthesia)
The degree of subjective difficulty experienced by the operator
operator's assessment of the subjective difficulty / handling of the device by means of a special analogue numerical scale from 1 to 5, where 1=no subjective difficulty and 5=maximal subjective difficulty
Measured: up to 15 minutes (from device insertion into the patient's mouth until the ETT will be positioned into the trachea)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start27 May 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway IntubationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abele Donati, MD, Università Politecnica delle Marche
- Investigators
- Abele Donati, PhD, MD, Study director, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532138
- Sponsor's protocol ID
- D-BLADE - VS
- Status last verified
- Aug 2020
- First submitted
- 21 Jul 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between C-MAC Video Laryngoscope an VS-CMAC Rigid Fiberoptic Stylet for Awake Endoscopic Intubation in Severe Predicted Difficult Airways: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04532138
- Acronym / sponsor ID
- D-BLADE - VS
- Conditions
- Difficult Airway Intubation
- Keywords
- difficult airway, difficult intubation, awake endoscopic intubation, rigid fiberoptic stylet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 31 Aug 2020 (actual)
- 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.
An Anticipated difficult tracheal intubation is recommended to be managed performing the so called "Awake tracheal endoscopic intubation" (ATI) with the maintenance of patient's spontaneous breathing after an adequate sedation and topical anesthesia of upper airways, providing supplemental oxygen.
Initially only flexible bronchoscope was considered the device of choice (the gold standard) for ATI but in the last decade videolaryngoscopes with hyper-angulated blade have been demonstrated to be an efficacy technique.
Most recently, endoscopic rigid stylets such as Bonfils (Carl Storz™) and Sensacope (Acoutronic™) have been proposed as alternative techniques for ATI in the event of expected difficult tracheal intubation.
However, to date, no comparison studies have been carried out between these two kind of devices, alternative to flexible fiberscope, for ATI.
This is a clinical prospective randomized-controlled trial of non inferiority. The aim of this study is to compare the intubation success rate between two different devices (C-MAC Video Laryngoscope and VS-CMAC fiberoptic stylet) in patients with severe predicted difficult airways scheduled for elective surgery.
The primary endpoint is the comparison of success rate for the tracheal intubation, demonstrating the non inferiority of videostylet efficacy compared to the most consolidated technique based on videolaryngoscope.
Detailed description
This is a clinical prospective randomized-controlled trial of non inferiority, set in the operating theatre of a terziary university hospital in Ancona (Ospedali Riuniti Ancona).
The aim of this study is to compare the intubation success rate, defined as correct positioning of the tracheal tube inside the trachea, between Videostylet (VS-Carl Storz™) and videolaryngoscope with hyperangulated blade (C-MAC - Carl Storz™) in patients with severe predicted difficult airways scheduled for elective surgery.
All patients enrolled in the study, examined in the pre-operative visit, will be asked for informed consent and will undergo the same anesthetic protocol consisting in upper airways topicalization with Lidocaine and in smooth/moderate sedation (targeted on Ramsay sedation scale ≦ 3) by i.v. administration of midazolam 0,03 mg/kg and Fentanyl 100 mcg.
On arrival in the operating room, nasal oxygen (5 L/min) and routine monitoring of vital signs will be applied to all patients.
Heart rate and blood pressure will be recorded at the beginning of the procedure and every 3 minutes until the intubation will be performed, while arterial oxygen saturation is continuously recorded.
Patients enrolled will be randomly divided into 2 groups regarding to the device used for ATI:
- Videolaryngoscope (C-MAC) with Hyperangulated blade (D-blade)
- Videostylet (VS) Endotracheal tube will be 6,5-7,0 mm for female and 7,5-8,0 mm for male.
The following parameters will be registered:
- success rate of the procedure defined as correct positioning of the tracheal tube in the trachea confirmed both endoscopically and through the capnographic curve EtCO2
- average time of intubation procedure expressed in sec.
- operator's assessment of the subjective difficulty / handling of the device by means of a special analogue numerical scale
- assessment of the patient's tolerance to the procedure by means of a special analogue numerical scale checked after patient's awakening from anesthesia at the end of the intervention.
- occurrence of any complications or adverse event during the procedure (desaturation episodes, hemodynamic changes, oral-pharynx and larynx traumatism)
The primary endpoint is the comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of videostylet efficacy compare to the most consolidated technique based on videolaryngoscope.
The Null Hypothesis will be the following: The rate of Awake tracheal intubation failure with the VS video stylet is > 10% compared to video-laryngoscope.
Considering an unsuccessful intubation rate with the two devices at 10%, a sample of 34 patients (17 per group) is necessary to demonstrate with a power of 90% and alpha error of 0.05 that the rate of intubation failure using the videosylet (study method) does not exceed 10% of the rate of failed intubations through the use of the video laryngoscope (reference method).
Statistical analysis:
Normally distributed data will be expressed as mean ± standard deviation and 95% confidence interval, while data with non-normal distribution will be expressed as median and interquartile range.
The differences between means will be studied by parametric tests (e.g. Student's t) if the data are normally distributed and by nonparametric tests (e.g. Wilcoxon) if the distribution is not normal. The Kolmogorov-Smirnov test will be used to evaluate the normality of continuous variables.
The characteristics of the patients in the two groups will be compared using the Fisher test or the Chi-square test for the nominal variables and the Student t test or the Mann - Whitney U test for the continuous variables.
For each test p < 0.05 will be considered significant. For the primary endpoint: The difference in awake tracheal intubation success rate in the two groups will be assessed using Fisher's exact test. The non-inferiority of the use of the videostylet (VS) compared to the standard method (videolaryngoscope with D-Blade blade) will be confirmed if the difference, for 95% confidence interval, is less than the margin of non- inferiority established "a priori" as 10% after analysis of the literature (Alhomary et al. Anaesthesia 2018; 73: 1151-61)9 and according to clinical judgment.
For the secondary endpoints of the study a purely analytical-descriptive evaluation will be carried out.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-MAC Video laryngoscope awake intubation | Active comparator | Device: C-MAC Video laryngoscope awake intubationIn this group, patients with severe predicted difficult airways scheduled for elective surgery receive awake endoscopic intubation using Videolaryngoscope (C-MAC) with Hyperangulated blade (D-blade) Spontaneous breathing will be preserved in both groups of patients enrolled and the same protocol of sedation plus upper airways topical anesthesia will be applied. |
| VS-CMAC Rigid Fiberoptic Stylet awake intubation | Experimental | Device: VS-CMAC Rigid Fiberoptic StyletIn this group, patients with severe predicted difficult airways scheduled for elective surgery receive awake endoscopic intubation using VS-CMAC Rigid Fiberoptic Stylet. Spontaneous breathing will be preserved in both groups of patients enrolled and the same protocol of sedation plus upper airways topical anesthesia will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Schedule for elective surgery
- Detection of one or more of the following anthropometric criteria predictive of difficult intubation at the preoperative visit:
Key exclusion criteria (4 listed)
- age <18 years
- refusal of the patient
- urgent-emergency surgery
- patient's respiratory failure
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 |
|---|---|---|
| VS-CMAC Rigid Fiberoptic Styletpatients with severe predicted difficult airways scheduled for elective surgery randomized to this groups will receive awake endoscopic intubation using VS-CMAC Rigid Fiberoptic Stylet. | Device | VS-CMAC Rigid Fiberoptic Stylet awake intubation |
| C-MAC Video laryngoscope awake intubationAlso: videolaryngoscope with hyperangulated bladepatients with severe predicted difficult airways scheduled for elective surgery randomized to this groups will receive awake endoscopic intubation using C-MAC Video Laryngoscope intubation. | Device | C-MAC Video laryngoscope awake intubation |
Primary outcome
the success rate of the rigid fiberoptic stylet to perform tracheal intubation in patients with anticipated difficult airways
Time frame: up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 minutes)
The primary endopoint is the comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of videostylet efficacy compare to the most consolidated technique based on videolaryngoscope. success rate of the procedure defined as correct positioning of the tracheal tube in the trachea confirmed both endoscopically and through the capnographic curve EtCO2
5 secondary outcomes
Numbers of intubation attempts
Time frame: up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 minutes)
average time of intubation procedure expressed in seconds
Time frame: up to 15 minutes
Development of any complications
Time frame: up to 12 hours measured from the insertion of the device
The degree of patient's tolerability of the procedure (with a special Analogue Numerical Scale)
Time frame: up to 12 hours from the beginning of the procedure (from starting of awake intubation to complete recovering from general anaesthesia)
The degree of subjective difficulty experienced by the operator
Time frame: up to 15 minutes (from device insertion into the patient's mouth until the ETT will be positioned into the trachea)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Abele Donati, PhD, MD study director
Università Politecnica delle Marche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VS-CMAC Rigid Fiberoptic Stylet and C-MAC Video laryngoscope awake intubation in people with Difficult Airway Intubation, run by Università Politecnica delle Marche at 1 site in Italy.
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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Aug 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abele Donati, PhD, MD (00390715963858, a.donati@univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the success rate of the rigid fiberoptic stylet to perform tracheal intubation in patients with anticipated difficult airways (time frame: up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 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 31 Aug 2020.