Clinical trial NCT03749837: C-MAC Video Stylet vs. Video Endoscope
Official title: Is a Rigid Fiberscope With a Flexible Tip Superior to Standard Flexible Fiberoptic Intubation: a Prospective Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time (seconds) to successful orotracheal intubation during the first successful attempt.
timeFrame: 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:
measure: Overall time from startpoint to glottic view
timeFrame: It cannot be longer than 240 seconds and is defined for unsuccessful trials, i.e. if no intubation was established, as 360 seconds.
measure: Time to first end expiratory CO2 reading
timeFrame: Start: Device passes patients lips; End: First end expiratory CO2 reading (trial in total not >240 seconds)
measure: Number of intubation attempts
timeFrame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
measure: Subjective difficulty of the intubation procedure
timeFrame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds
measure: Cormack/Lehane grade
timeFrame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
measure: Limited or restricted vision through the devices (either C MAC VS or a standard flexible scope)
timeFrame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
measure: Correlation to patients' anatomical characteristics
timeFrame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
measure: Patients vital parameter such as heart rate, during the intubation attempt
timeFrame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
measure: Patients vital parameter such as blood pressure, during the intubation attempt
timeFrame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
measure: Patients vital parameter such as oxygen saturation, during the intubation attempt
timeFrame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
measure: Participants characteristics and demographic data
timeFrame: Before the study session starts (up to 24 hours before the first intubation attempt)
measure: Patients demographic data such as height
timeFrame: During the process of screening, up to 24 hours before the study session starts
measure: Patients demographic data such as weight
timeFrame: During the process of screening, up to 24 hours before the study session starts
measure: Patients demographic data such as ASA risc classification (ASA= American Society of Anaesthesiologists)
timeFrame: During the process of screening, up to 24 hours before the study session starts
measure: Patients demographic data such as age
timeFrame: During the process of screening, up to 24 hours before the study session starts
measure: Patients demographic data such as gender
timeFrame: During the process of screening, up to 24 hours before the study session starts
Other outcomes:
measure: Incidence of injuries due to intubation attempts
timeFrame: Follow-Up on the first post anaesthesia day (maximum 24 hours post anaesthesia)
measure: How often a "hand over to specialist" happens
timeFrame: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
Locations:
city: London
country: Canada
facility: LHSC / St. Joesephs
state: Ontario
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
Study officials:
affiliation: Department of Anaesthesiology and Pain Therapy
name: Lorenz Theiler, Prof., M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Halligan 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.
citation: Isono 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.
citation: Levitan 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.
citation: Sakles 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.
citation: Dalal 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.
citation: Smith 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.