Awake Intubation V-MAC VS

NCT03742830 | Completed

• 1 other identifier: 2018-01454
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays, the gold standard for difficult airway management is awake intubation with a flexible fiberscope. Alternatively, when the flexible fiberscope is unable to facilitate tracheal intubation, rigid stylets may be used. One newly developed rigid video stylet also features a flexible tip (C-MAC VS, Karl Storz AG, 78532 Tuttlingen, Germany). The distal angular offset of the C-MAC VS, in which the camera and light sources are integrated, can be aligned (up to 60°) to the patient's anatomical structures to facilitate intubation. Although awake intubation is less comfortable for the patient and more time consuming, there are several reasons why this is often performed. The investigators plan a prospective observational with 36 participants using the C-MAC VS on adult patients with indication for awake oral intubation. To ease the placement of the tube (intubation), the investigators will use local anesthesia of the mucosa in the mouth, pharynx and larynx. The main purpose of the study is to prove the feasibility of successful awake intubation with the C-MAC VS in adult patients. If the new device proves reliable in facilitating awake oral, future patients benefit from an additional tool that allows fast and safe intubation in difficult airway situations.

Conditions

Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

• Intubation success

  The intubation success rate at first attempt in less than 120 seconds

  120 seconds

Secondary Outcomes (12)

• Airway- and intubation data

  Device passes patients lips until the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown (the entire process should not pass 120 seconds)

• Duration of the airway management

  Device passes patients lips until the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown (the entire process should not pass 120 seconds)

• Patient's comfort during intubation

  On the 1st post-procedure day

• Total number of intubation attempts

  The first time the device passes patients lips until the respiratory is secured so the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown.

• Patients demographic data such as weight

  During the process of screening, up to 24 hours before the study session starts

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

Study Population

All adult patients undergoing general anaesthesia for an elective prodcedure at the University Hospital of Bern will be screened using the Anästhesie Informations System (AIS). If a patient meets our inclusion/exclusion criteria, the investigators will visit him personally and confirm, that all criteria are met. Then, written informed consent will be obtained and the study can begin.

You may qualify if:

• indication for awake oral intubation
• elective surgery
• age 18-80
• written Informed Consent
• knowledge of the German language enough to understand the Informed Consent

You may not qualify if:

• emergency patients
• uncooperative patients
• ASA (= Physical Status Classification System) V
• study equipment and personal not available

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (3)

• Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.

  PMID: 21447488 BACKGROUND

• Ovassapian A. The flexible bronchoscope. A tool for anesthesiologists. Clin Chest Med. 2001 Jun;22(2):281-99. doi: 10.1016/s0272-5231(05)70043-5.

  PMID: 11444112 BACKGROUND

• Falcetta S, Pecora L, Orsetti G, Gentili P, Rossi A, Gabbanelli V, Adrario E, Donati A, Pelaia P. The Bonfils fiberscope: a clinical evaluation of its learning curve and efficacy in difficult airway management. Minerva Anestesiol. 2012 Feb;78(2):176-84. Epub 2011 Nov 18.

  PMID: 22095109 BACKGROUND

Study Officials

• Robert Greif, Prof.Dr.med.

  University Hospital of Bern, Bern, Switzerland

  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: November 15, 2018
• Study Start: February 6, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

CH (1)