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Awake Intubation V-MAC VS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742830
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date November 9, 2018
First Posted Date November 15, 2018
Last Update Posted Date January 29, 2020
Actual Study Start Date February 6, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2018)
Intubation success [ Time Frame: 120 seconds ]
The intubation success rate at first attempt in less than 120 seconds
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 14, 2018)
  • 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)
  • 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
  • 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).
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Awake Intubation V-MAC VS
Official Title Awake Intubation in Difficult Airway- a Prospective Observational Study
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 14, 2018)
36
Original Estimated Enrollment Same as current
Actual Study Completion Date September 30, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03742830
Other Study ID Numbers 2018-01454
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators Not Provided
Investigators
Principal Investigator: Robert Greif, Prof.Dr.med. University Hospital of Bern, Bern, Switzerland
PRS Account University Hospital Inselspital, Berne
Verification Date January 2020