Awake Intubation V-MAC VS

Intubation;Difficult Clinical Trial

Official title:

Awake Intubation in Difficult Airway- a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742830
• Other study ID #: 2018-01454
• Status: Completed
• Start date: February 6, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation;Difficult

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

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. — View Citation

Ovassapian A. The flexible bronchoscope. A tool for anesthesiologists. Clin Chest Med. 2001 Jun;22(2):281-99. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation success	The intubation success rate at first attempt in less than 120 seconds	120 seconds
Secondary	Airway- and intubation data	Interim times of airway management (intubation start, first view of vocal cords, device out of the tube - first end tidal CO2)	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)
Secondary	Duration of the airway management	The period of time that is needed for the airway management and the respiratory security	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)
Secondary	Patient's comfort during intubation	The investigators will evaluate their comfort during intubation on the 1st post-procedure day on a VAS (visual analogue pain scale) 1-10 (1: very easy, 10: very hard).	On the 1st post-procedure day
Secondary	Total number of intubation attempts	The total number that is needed to secure the airway with intubation	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.
Secondary	Patients demographic data such as weight	The weight of each patient will be presented in kilograms	During the process of screening, up to 24 hours before the study session starts
Secondary	Patients demographic data such as size	The size of each patient will be presented in meter/centimeter	During the process of screening, up to 24 hours before the study session starts
Secondary	Patients demographic data such as gender	The gender (female or male) will be presented	During the process of screening, up to 24 hours before the study session starts
Secondary	Patients demographic data such as BMI	Weight and Height will be combined to report BMI in kg/m2	During the process of screening, up to 24 hours before the study session starts
Secondary	Patients vital parameter such as blood pressure	The investigators will use the standard non-invasive monitoring of the University Hospital to measure the blood pressure (in millimeters of mercury)	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)
Secondary	Patients vital parameter such as heart rate	The investigators will use the standard non-invasive monitoring of the University Hospital to measure the heart rate (beats per minute)	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)
Secondary	Patients vital parameter such as the arterial oxygen saturation	The investigators will use the standard non-invasive monitoring of the University Hospital to measure the arterial oxygen saturation (SaO2 in percent)	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)
Secondary	The anesthetist rates the patients airway	The anesthetist rates the POGO (Percentage of Glottis Opening), the quality of the vision device and the intubation difficulty on a VAS (visual analogue pain scale) 1-10 (1: very easy, 10: very hard).	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)