C-MAC Video Stylet vs. Video Endoscope

NCT03749837 | Completed

• 1 other identifier: 2018-00629
• Study Type: interventional
• Target: 18
• Locations: 3 countries
• Sites: 3

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.

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

• Time (seconds) to successful orotracheal intubation during the first successful attempt.

  With the C-MAC VS and the standard flexible scope

  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

  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

  Start: Device passes patients lips; End: First end expiratory CO2 reading (trial in total not >240 seconds)

• Number of intubation attempts

  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

  Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds

• Cormack/Lehane grade

  Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)

Other Outcomes (2)

• Incidence of injuries due to intubation attempts

  Follow-Up on the first post anaesthesia day (maximum 24 hours post anaesthesia)

• How often a "hand over to specialist" happens

  Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)

Study Arms (2)

C- MAC VS

EXPERIMENTAL

Intubation with C- MAC VS

Device: C- MAC VS

Video Endoscope

ACTIVE COMPARATOR

Intubation with standard fiberoptic scope

Device: Video Endoscope

Interventions

C- MAC VS 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.

C- MAC VS

Video Endoscope 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.

Video Endoscope

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (3)

LHSC / St. Joesephs

London, Ontario, Canada

Location

Miguel Servet University Hospital

Zaragoza, Spain

Location

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 27670928 BACKGROUND

• 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.

  PMID: 14616594 BACKGROUND

• 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.

  PMID: 22074073 BACKGROUND

• 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.

  PMID: 11145770 BACKGROUND

• 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.

  PMID: 23574475 BACKGROUND

• 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.

  PMID: 21710368 BACKGROUND

• 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.

  PMID: 9059089 BACKGROUND

MeSH Terms

Interventions

Capsule Endoscopes

Intervention Hierarchy (Ancestors)

Endoscopes, Gastrointestinal; Endoscopes; Diagnostic Equipment; Equipment and Supplies

Study Officials

• Lorenz Theiler, Prof., M.D

  Department of Anaesthesiology and Pain Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 21, 2018
• Study Start: December 15, 2018
• Primary Completion: July 30, 2024
• Study Completion: July 31, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); CA (1); ES (1)