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Completed

NCT Number: NCT03742830

Awake Intubation V-MAC VS

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.

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Key information

Conditions

Intubation;Difficult

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intubation success

    Time frame: 120 seconds

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

Secondary outcomes

  1. Airway- and intubation data

    Time frame: 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)

    Interim times of airway management (intubation start, first view of vocal cords, device out of the tube - first end tidal CO2)

  2. Duration of the airway management

    Time frame: 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)

    The period of time that is needed for the airway management and the respiratory security

  3. Patient's comfort during intubation

    Time frame: On the 1st post-procedure day

    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).

  4. Total number of intubation attempts

    Time frame: 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.

    The total number that is needed to secure the airway with intubation

  5. Patients demographic data such as weight

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

    The weight of each patient will be presented in kilograms

  6. Patients demographic data such as size

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

    The size of each patient will be presented in meter/centimeter

  7. Patients demographic data such as gender

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

    The gender (female or male) will be presented

  8. Patients demographic data such as BMI

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

    Weight and Height will be combined to report BMI in kg/m2

  9. Patients vital parameter such as blood pressure

    Time frame: 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)

    The investigators will use the standard non-invasive monitoring of the University Hospital to measure the blood pressure (in millimeters of mercury)

  10. Patients vital parameter such as heart rate

    Time frame: 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)

    The investigators will use the standard non-invasive monitoring of the University Hospital to measure the heart rate (beats per minute)

  11. Patients vital parameter such as the arterial oxygen saturation

    Time frame: 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)

    The investigators will use the standard non-invasive monitoring of the University Hospital to measure the arterial oxygen saturation (SaO2 in percent)

  12. The anesthetist rates the patients airway

    Time frame: 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)

    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).

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Awake Intubation in Difficult Airway- a Prospective Observational Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2018
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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