C-MAC Video Stylet vs. Video Endoscope

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-15

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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

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Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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C- MAC VS

Intubation with C- MAC VS

Group Type EXPERIMENTAL

C- MAC VS

Intervention Type DEVICE

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 Endoscope

Intubation with standard fiberoptic scope

Group Type ACTIVE_COMPARATOR

Video Endoscope

Intervention Type DEVICE

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.

Interventions

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C- MAC VS

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.

Intervention Type DEVICE

Video Endoscope

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)

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)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes