C-MAC Video Stylet vs. Video Endoscope

Last updated: June 3, 2025
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

C- MAC VS

Video Endoscope

Clinical Study ID

NCT03749837
2018-00629
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Anaesthesiologists starting in the respective anaesthesia department who are notexperienced 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)

Exclusion

Exclusion Criteria:

  • 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)

Study Design

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: C- MAC VS
Phase:
Study Start date:
December 15, 2018
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • LHSC / St. Joesephs

    London, Ontario
    Canada

    Site Not Available

  • Miguel Servet University Hospital

    Zaragoza,
    Spain

    Site Not Available

  • Inselspital, Bern University Hospital

    Bern, 3010
    Switzerland

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.