Awake Intubation V-MAC VS

NCT ID: NCT03742830

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-06
• Study Completion Date: 2019-09-30

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.

Detailed Description

In the majority of cases, airway management is uncomplicated and a straightforward procedure. Nevertheless, in rare cases complications are associated with notably high rates of serious consequences.

Therefore, assured and reliable intubation is fundamental to safe anesthetic practice.

Various approaches were introduced by the medical device industry to optimize intubation procedure. 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 C-MAC VS is an advancement of the rigid "Bonfils" stylet (Karl Storz, Karl Storz AG, 78532 Tuttlingen, Germany). The distal angular offset of the C-MAC VS, in which the camera and light source 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.

In this research project, the investigators plan a prospective observational study using the C-MAC VS on adult patients with indication for awake oral intubation. Spontaneous ventilation will be maintained until confirmation of tracheal 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 study physician will intubate the trachea of the patient using the C-MAC VS. Another person of the study team will record the primary and secondary outcomes on the Case Report Form.

After intubation, the anesthetist evaluates the intubation. Participants will be followed up for procedure related complications after the intubation and on the 1st post-anesthesia day to evaluate patient intubation comfort (VAS 1: very easy to 10: very hard).

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

C-MAC VS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Greif, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Bern, Bern, Switzerland

Locations

Inselspital, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 21447488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11444112 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22095109 (View on PubMed)

Other Identifiers

2018-01454

Identifier Type: -

Identifier Source: org_study_id