C-MAC VS Clinical Observation

NCT03856398 | Terminated

• 1 other identifier: 2018-01452
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

During orotracheal intubation failure in securing an airway can result in serious oxygenation problems. Beside the classic laryngoscopes and fibreoptic scopes, devices with high-resolution video cameras placed in the tip of the devices, were developed and attained in daily routines. Studies and case reports reveal them to be superior in both normal and difficult intubation, especially improving the first-attempt success rate. Latest advancements of the Bonfils fiberscope resulted in the C-MAC VS, which combines rigid and semi-rigid abilities to a rigid video stylet with a flexible tip. Because of its front positioned high-resolution camera resulting in an indirect visualization, it may also have the benefits of video laryngoscopes. Very little data is available on larger numbers of use and the investigators do not know about rare side effects and complications with the use of the device, such as esophageal intubations. Due to its direct view and positioning on vocal cord level, the investigators expect a similar or even lower rate of endotracheal intubation, using the C-MAC VS. The investigators therefore plan to analyze the use of the C-MAC VS regarding its efficiency and safety during airway management in everyday clinical practice. This should provide the evidence about safe use, possible risk factors, rare complications and adverse events, as well as the preferred clinical airway situations to use the C-MAC VS.

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (1)

• First-attempt oro-tracheal intubation success rate in percentage

  Rate of a successful intubation at first attempt

  The overall rate of successful intubation at first attempt. The study will end when the tracheal tube is placed properly and the airway is secured (the first attempt should not pass 120 seconds)

Secondary Outcomes (11)

• Overall success rate

  Intraoperative (The study will end when the tracheal tube is placed properly and the airway is secured.)

• Number of attempts

  Intraoperative (Starts when the device is inserted in the patients mouth and ends when the airway is secured.)

• Difficulty of intubation

  Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds

• Preferred method used to lift the tongue ventral to increase space in the oral cavity and the approach

  The beginning of the intubation procedure, when the device is inserted in the patients mouth. Estimated time 120 seconds

• Tube size used

  Baseline

Interventions

C- MAC VS DEVICE

C-MAC VS, Karl Storz AG, 78532 Tuttlingen, Germany It has a flexible tip and a distal angular offset, in which the camera and light sources are integrated. It can be aligned (up to 60°) to the patient's anatomical structures to facilitate intubation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing general anaesthesia for elective procedures at the Bern University Hospital will be screened using the Anesthesia Information System (AIS). Patients that meet the inclusion criteria, we will visited to confirm that and the given general consent.

You may qualify if:

• Patients for elective and emergency surgery who have at least one predictor for difficult airway management, which are: Mallampati score \>2, mouth opening \<4cm, thyromental distance \<6cm, head \& neck movements \<90°, short neck, reduced reclination.
• Patients who signed general research consent in Switzerland.

You may not qualify if:

• Patients under the age of 18 years
• Personnel at the study site not available of not sufficient ted in the device.
• Expected impossible mask ventilation
• High risk of aspiration (requiring rapid sequence induction intubation)
• Intracranial surgery
• Limited knowledge of German language or refusing general consent.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital and University of Bern

Bern, 3011, Switzerland

Location

Related Publications (7)

• Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.

  PMID: 15271750 BACKGROUND

• Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology. 2005 Jul;103(1):33-9. doi: 10.1097/00000542-200507000-00009.

  PMID: 15983454 BACKGROUND

• Williams KN, Carli F, Cormack RS. Unexpected, difficult laryngoscopy: a prospective survey in routine general surgery. Br J Anaesth. 1991 Jan;66(1):38-44. doi: 10.1093/bja/66.1.38.

  PMID: 1997057 BACKGROUND

• Maassen R, Lee R, van Zundert A, Cooper R. The videolaryngoscope is less traumatic than the classic laryngoscope for a difficult airway in an obese patient. J Anesth. 2009;23(3):445-8. doi: 10.1007/s00540-009-0780-1. Epub 2009 Aug 14.

  PMID: 19685133 BACKGROUND

• Choi JW, Kim JA, Jung HJ, Kim WH. Tracheal Intubation with a McGrath(R) Series 5 Video Laryngoscope by Novice Personnel in a Cervical-immobilized Manikin. J Emerg Med. 2016 Jan;50(1):61-6. doi: 10.1016/j.jemermed.2015.06.079. Epub 2015 Oct 1.

  PMID: 26432080 BACKGROUND

• Burdett E, Ross-Anderson DJ, Makepeace J, Bassett PA, Clarke SG, Mitchell V. Randomized controlled trial of the A.P. Advance, McGrath, and Macintosh laryngoscopes in normal and difficult intubation scenarios: a manikin study. Br J Anaesth. 2011 Dec;107(6):983-8. doi: 10.1093/bja/aer295. Epub 2011 Sep 22.

  PMID: 21940397 BACKGROUND

• Kory P, Guevarra K, Mathew JP, Hegde A, Mayo PH. The impact of video laryngoscopy use during urgent endotracheal intubation in the critically ill. Anesth Analg. 2013 Jul;117(1):144-9. doi: 10.1213/ANE.0b013e3182917f2a. Epub 2013 May 17.

  PMID: 23687228 BACKGROUND

Study Officials

• Robert Greif, Prof., MD

  Department of Anaesthesiology and Pain Therapy, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: February 27, 2019
• Study Start: March 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

CH (1)