IntubationNCT03749837
C-MAC Video Stylet vs. Video Endoscope
A study testing C- MAC VS and Video Endoscope in people with Intubation, run by Insel Gruppe AG, University Hospital Bern at 3 sites in 3 countries.
Trial summary
The purpose of the study is to compare first attempt success rates and time until intubation to establish the learning curves of the participating anaesthesiologists with two different intubation strategies: (Karl Storz C-MAC VS (Video Stylet) and the standard flexible intubation video endoscope at the study site. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intubation
- What is being tested?
- C- MAC VS and Video Endoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Dec 2018to 31 Jul 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Anaesthesiologists starting in the respective anaesthesia department who are not experienced with tracheal intubation with the study devices
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Novice to the C-MAC VS
- No/few fiberoptic oral asleep intubation experience (max. 5x during the last year)
Who cannot join
- More than 5 uses during the past year of either one of the study devices
- Not available at the study site during entire study (expected drop outs)
- Not able to fill out English case reports
- Patients: Planned delayed extubation (e.g. planned transfer to ICU)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Is a Rigid Fiberscope With a Flexible Tip Superior to Standard Flexible Fiberoptic Intubation: a Prospective Multicentre Randomised Controlled Trial
The purpose of the study is to compare first attempt success rates and time until intubation to establish the learning curves of the participating anaesthesiologists with two different intubation strategies: (Karl Storz C-MAC VS (Video Stylet) and the standard flexible intubation video endoscope at the study site.
Read the detailed description
The intubation of the trachea is a crucial procedure in anaesthesia and emergency medicine, therefore it is considered as one of the core competences in these disciplines. Novices in the field need to learn intubation fast and without harming patients to ensure a patent airway if needed.
According to the European Union of Medical Specialists (U.E.M.S., 1050 Brussels, BE), every anaesthesiologist has to master different techniques for the airway management. One is the fiberoptic intubation in awake or asleep patients, to manage a difficult airway. For further training, these core competences need to be extended during the career, from level A (has knowledge) to level D (teaches or supervises others). As the intubation with flexible fiberoptic scopes is the gold standard for the management of a known difficult airway, the investigators want to compare this to a new technique. The use of flexible scopes do not guarantee easy intubation in every difficult airway situation and intubation sometimes is difficult to achieve and requires high proficiency (unability to steer, unability to overcome an anatomical obstacle). Various approaches were introduced by the medical device industry to overcome that problem. One new device is a rigid video stylet with a flexible tip (Karl Storz C-MAC VS), which is an advancement of the older rigid scope "Bonfils" (Karl Storz).
Intubation training with the Bonfils stylet has been shown to require about 20 consecutive tracheal intubations by novices to reach expert time. Learning curves for fiberoptic intubations seem to be similar, but a greater variance was observed. A study of the investigators research-group (unpublished data, KEK 247/09), comparing learning curves between the rigid fiberoptic Bonfils and the semi-rigid fiberoptic SensaScope suggested a 90% success rate for intubation within 60 seconds after about 15 trials (Bonfils) and 20 trials (SensaScope). In comparison, there is no validated data for the use of rigid scopes with flexible tips, as these tool are very new.
Video stylets are tools originally designed for difficult airway management as well. The C-MAC VS combines rigid and semi-rigid abilities. Intubation seems to become very easy. But yet, there is no data available which proves that assumption. Thus the study wants to evaluate if intubation success and time is superior with the C-MAC Video Scope compared to the difficult intubation gold standard, the intubation with a standard flexible fiberoptic scope.
- Conditions
- Intubation
- Being tested
- C- MAC VS, Video Endoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C- MAC VSDevice
The C-MAC VS is a new device on the airway management aid market. It will be used according to the instructions of the distributor. Before the study starts on humans, each study participants will do at least 5 intubations on an airway manikin or more until he or she feels confident to use the device.
Video EndoscopeDevice
Fiberoptic video endoscopic devices are standard aids to facilitate intubation on all study sites and are used according to the instructions to use. To facilitate fiberoptic intubation a macintosh blade to raise the root of tongue will be used. Also with these devices the study participants need at least 5 trials to intubate a manikin (or more to feel confident) before they are going to use the study device in patients.
| Study group | Role | What they receive |
|---|---|---|
| C- MAC VS | Experimental | Intubation with C- MAC VS Receives: Device: C- MAC VS |
| Video Endoscope | Active comparator | Intubation with standard fiberoptic scope Receives: Device: Video Endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (seconds) to successful orotracheal intubation during the first successful attempt.
With the C-MAC VS and the standard flexible scope
Measured: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (a trial consists of a maximum of 2 intubation attempts, each with a maximum duration of 120 seconds)
Secondary outcomes (16)
Overall time from startpoint to glottic view
The overall time is defined as the total time to glottic view, summarized over all attempts.
Measured: It cannot be longer than 240 seconds and is defined for unsuccessful trials, i.e. if no intubation was established, as 360 seconds.
Time to first end expiratory CO2 reading
After the airway is secured the first end expiratory CO2 is shown.The investigators will use the standard non-invasive monitoring of the University Hospital to measure the end expiratory CO2
Measured: Start: Device passes patients lips; End: First end expiratory CO2 reading (trial in total not >240 seconds)
Number of intubation attempts
End of an attempt defined as: device has to be completely removed out of the patient's airway.
Measured: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Subjective difficulty of the intubation procedure
The VAS- Visual analogue scale (score 1-10) is used. It is a measurement instrument for subjective characteristics that cannot be directly measured. Therefore numbers are used to evaluate.
Measured: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds
Cormack/Lehane grade
The Cormack/Lehane grade is used to describe the laryngeal view during laryngoscopy. It is rated by the supervisor.
Measured: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Limited or restricted vision through the devices (either C MAC VS or a standard flexible scope)
The view can be clear or blurred.
Measured: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Correlation to patients' anatomical characteristics
To assess the influence of difficulty with the airway
Measured: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Patients vital parameter such as heart rate, during the intubation attempt
The investigators will use the standard non-invasive monitoring of the University Hospital to measure the heart rate.
Measured: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Patients vital parameter such as blood pressure, during the intubation attempt
The investigators will use the standard non-invasive monitoring of the University Hospital to measure the blood pressure (in millimeters of mercury)
Measured: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Patients vital parameter such as oxygen saturation, during the intubation attempt
The investigators will use the standard non-invasive monitoring of the University Hospital to measure the oxygen saturation (SpO2 in percent).
Measured: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Participants characteristics and demographic data
Basic demographic data (including years of experience in anaesthesia).
Measured: Before the study session starts (up to 24 hours before the first intubation attempt)
Patients demographic data such as height
The size of each patient will be presented in meter/centimeter
Measured: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as weight
The weight of each patient will be presented in kilograms
Measured: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as ASA risc classification (ASA= American Society of Anaesthesiologists)
The ASA grading system is used to evaluate the degree of a patient's physical state before selecting the anesthetic or before performing surgery.
Measured: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as age
The age of each patient will be presented in years.
Measured: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as gender
The gender of each patient will be presented in female or male.
Measured: During the process of screening, up to 24 hours before the study session starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start15 Dec 2018
- Primary completion30 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenz Theiler, Prof., M.D, Principal investigator, Department of Anaesthesiology and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749837
- Sponsor's protocol ID
- 2018-00629
- Other IDs
- 2018
- Status last verified
- Jun 2025
- First submitted
- 8 Nov 2018
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kleine-Brueggeney M, Greif R, Urwyler N, Wirthmuller B, Theiler L. The performance of rigid scopes for tracheal intubation: a randomised, controlled trial in patients with a simulated difficult airway. Anaesthesia. 2016 Dec;71(12):1456-1463. doi: 10.1111/anae.13626. Epub 2016 Sep 27.
PubMed 27670928Halligan M, Charters P. A clinical evaluation of the Bonfils Intubation Fibrescope. Anaesthesia. 2003 Nov;58(11):1087-91. doi: 10.1046/j.1365-2044.2003.03407.x.
PubMed 14616594Isono S, Greif R, Mort TC. Airway research: the current status and future directions. Anaesthesia. 2011 Dec;66 Suppl 2:3-10. doi: 10.1111/j.1365-2044.2011.06928.x.
PubMed 22074073Levitan RM, Goldman TS, Bryan DA, Shofer F, Herlich A. Training with video imaging improves the initial intubation success rates of paramedic trainees in an operating room setting. Ann Emerg Med. 2001 Jan;37(1):46-50. doi: 10.1067/mem.2001.111516.
PubMed 11145770Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
PubMed 23574475Dalal PG, Dalal GB, Pott L, Bezinover D, Prozesky J, Bosseau Murray W. Learning curves of novice anesthesiology residents performing simulated fibreoptic upper airway endoscopy. Can J Anaesth. 2011 Sep;58(9):802-9. doi: 10.1007/s12630-011-9542-2. Epub 2011 Jun 28.
PubMed 21710368Smith JE, Jackson AP, Hurdley J, Clifton PJ. Learning curves for fibreoptic nasotracheal intubation when using the endoscopic video camera. Anaesthesia. 1997 Feb;52(2):101-6. doi: 10.1111/j.1365-2044.1997.23-az023.x.
PubMed 9059089
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Rigid Fiberscope With a Flexible Tip Superior to Standard Flexible Fiberoptic Intubation: a Prospective Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03749837
- Acronym / sponsor ID
- 2018-00629
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Nov 2018 (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.
The purpose of the study is to compare first attempt success rates and time until intubation to establish the learning curves of the participating anaesthesiologists with two different intubation strategies: (Karl Storz C-MAC VS (Video Stylet) and the standard flexible intubation video endoscope at the study site.
Detailed description
The intubation of the trachea is a crucial procedure in anaesthesia and emergency medicine, therefore it is considered as one of the core competences in these disciplines. Novices in the field need to learn intubation fast and without harming patients to ensure a patent airway if needed.
According to the European Union of Medical Specialists (U.E.M.S., 1050 Brussels, BE), every anaesthesiologist has to master different techniques for the airway management. One is the fiberoptic intubation in awake or asleep patients, to manage a difficult airway. For further training, these core competences need to be extended during the career, from level A (has knowledge) to level D (teaches or supervises others). As the intubation with flexible fiberoptic scopes is the gold standard for the management of a known difficult airway, the investigators want to compare this to a new technique. The use of flexible scopes do not guarantee easy intubation in every difficult airway situation and intubation sometimes is difficult to achieve and requires high proficiency (unability to steer, unability to overcome an anatomical obstacle). Various approaches were introduced by the medical device industry to overcome that problem. One new device is a rigid video stylet with a flexible tip (Karl Storz C-MAC VS), which is an advancement of the older rigid scope "Bonfils" (Karl Storz).
Intubation training with the Bonfils stylet has been shown to require about 20 consecutive tracheal intubations by novices to reach expert time. Learning curves for fiberoptic intubations seem to be similar, but a greater variance was observed. A study of the investigators research-group (unpublished data, KEK 247/09), comparing learning curves between the rigid fiberoptic Bonfils and the semi-rigid fiberoptic SensaScope suggested a 90% success rate for intubation within 60 seconds after about 15 trials (Bonfils) and 20 trials (SensaScope). In comparison, there is no validated data for the use of rigid scopes with flexible tips, as these tool are very new.
Video stylets are tools originally designed for difficult airway management as well. The C-MAC VS combines rigid and semi-rigid abilities. Intubation seems to become very easy. But yet, there is no data available which proves that assumption. Thus the study wants to evaluate if intubation success and time is superior with the C-MAC Video Scope compared to the difficult intubation gold standard, the intubation with a standard flexible fiberoptic scope.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C- MAC VS | Experimental | Device: C- MAC VSIntubation with C- MAC VS |
| Video Endoscope | Active comparator | Device: Video EndoscopeIntubation with standard fiberoptic scope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Anaesthesiologists starting in the respective anaesthesia department who are not experienced with tracheal intubation with the study devices
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Novice to the C-MAC VS
- No/few fiberoptic oral asleep intubation experience (max. 5x during the last year)
Key exclusion criteria (4 listed)
- More than 5 uses during the past year of either one of the study devices
- Not available at the study site during entire study (expected drop outs)
- Not able to fill out English case reports
- Patients: Planned delayed extubation (e.g. planned transfer to ICU)
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 |
|---|---|---|
| C- MAC VSThe C-MAC VS is a new device on the airway management aid market. It will be used according to the instructions of the distributor. Before the study starts on humans, each study participants will do at least 5 intubations on an airway manikin or more until he or she feels confident to use the device. | Device | C- MAC VS |
| Video EndoscopeFiberoptic video endoscopic devices are standard aids to facilitate intubation on all study sites and are used according to the instructions to use. To facilitate fiberoptic intubation a macintosh blade to raise the root of tongue will be used. Also with these devices the study participants need at least 5 trials to intubate a manikin (or more to feel confident) before they are going to use the study device in patients. | Device | Video Endoscope |
Primary outcome
Time (seconds) to successful orotracheal intubation during the first successful attempt.
Time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (a trial consists of a maximum of 2 intubation attempts, each with a maximum duration of 120 seconds)
With the C-MAC VS and the standard flexible scope
16 secondary outcomes
Overall time from startpoint to glottic view
Time frame: It cannot be longer than 240 seconds and is defined for unsuccessful trials, i.e. if no intubation was established, as 360 seconds.
Time to first end expiratory CO2 reading
Time frame: Start: Device passes patients lips; End: First end expiratory CO2 reading (trial in total not >240 seconds)
Number of intubation attempts
Time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Subjective difficulty of the intubation procedure
Time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds
Cormack/Lehane grade
Time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Limited or restricted vision through the devices (either C MAC VS or a standard flexible scope)
Time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Correlation to patients' anatomical characteristics
Time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Patients vital parameter such as heart rate, during the intubation attempt
Time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Patients vital parameter such as blood pressure, during the intubation attempt
Time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Patients vital parameter such as oxygen saturation, during the intubation attempt
Time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Participants characteristics and demographic data
Time frame: Before the study session starts (up to 24 hours before the first intubation attempt)
Patients demographic data such as height
Time frame: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as weight
Time frame: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as ASA risc classification (ASA= American Society of Anaesthesiologists)
Time frame: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as age
Time frame: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as gender
Time frame: During the process of screening, up to 24 hours before the study session starts
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 6 Jun 2025.
- Background: PubMed 27670928Kleine-Brueggeney M, Greif R, Urwyler N, Wirthmuller B, Theiler L. The performance of rigid scopes for tracheal intubation: a randomised, controlled trial in patients with a simulated difficult airway. Anaesthesia. 2016 Dec;71(12):1456-1463. doi: 10.1111/anae.13626. Epub 2016 Sep 27.
- Background: PubMed 14616594Halligan M, Charters P. A clinical evaluation of the Bonfils Intubation Fibrescope. Anaesthesia. 2003 Nov;58(11):1087-91. doi: 10.1046/j.1365-2044.2003.03407.x.
- Background: PubMed 22074073Isono S, Greif R, Mort TC. Airway research: the current status and future directions. Anaesthesia. 2011 Dec;66 Suppl 2:3-10. doi: 10.1111/j.1365-2044.2011.06928.x.
- Background: PubMed 11145770Levitan RM, Goldman TS, Bryan DA, Shofer F, Herlich A. Training with video imaging improves the initial intubation success rates of paramedic trainees in an operating room setting. Ann Emerg Med. 2001 Jan;37(1):46-50. doi: 10.1067/mem.2001.111516.
- Background: PubMed 23574475Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
- Background: PubMed 21710368Dalal PG, Dalal GB, Pott L, Bezinover D, Prozesky J, Bosseau Murray W. Learning curves of novice anesthesiology residents performing simulated fibreoptic upper airway endoscopy. Can J Anaesth. 2011 Sep;58(9):802-9. doi: 10.1007/s12630-011-9542-2. Epub 2011 Jun 28.
- Background: PubMed 9059089Smith JE, Jackson AP, Hurdley J, Clifton PJ. Learning curves for fibreoptic nasotracheal intubation when using the endoscopic video camera. Anaesthesia. 1997 Feb;52(2):101-6. doi: 10.1111/j.1365-2044.1997.23-az023.x.
- 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.
Lorenz Theiler, Prof., M.D principal investigator
Department of Anaesthesiology and Pain Therapy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C- MAC VS and Video Endoscope in people with Intubation, run by Insel Gruppe AG, University Hospital Bern at 3 sites in 3 countries.
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 4 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: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Spain, Switzerland. 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?
Time (seconds) to successful orotracheal intubation during the first successful attempt. (time frame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (a trial consists of a maximum of 2 intubation attempts, each with a maximum duration of 120 seconds)). 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 NCT03749837, which also lists 7 linked publications.
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 6 Jun 2025.