- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03742830
Awake Intubation V-MAC VS
Awake Intubation in Difficult Airway- a Prospective Observational Study
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.
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3010
- Inselspital, Bern University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intubation success
Time Frame: 120 seconds
|
The intubation success rate at first attempt in less than 120 seconds
|
120 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
During the process of screening, up to 24 hours before the study session starts
|
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)
|
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
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
|
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
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).
|
On the 1st post-procedure day
|
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
|
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 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
|
During the process of screening, up to 24 hours before the study session starts
|
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
|
During the process of screening, up to 24 hours before the study session starts
|
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
|
During the process of screening, up to 24 hours before the study session starts
|
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)
|
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)
|
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)
|
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)
|
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)
|
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 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).
|
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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert Greif, Prof.Dr.med., University Hospital of Bern, Bern, Switzerland
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-01454
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intubation;Difficult
-
Lazarski UniversityCompletedIntubation; Difficult or Failed | Difficult Airway | Intubation;DifficultPoland
-
Catharina Ziekenhuis EindhovenCompletedAnesthesia Intubation Complication | Intubation; Difficult | Failed or Difficult Intubation | Failed or Difficult Intubation, Initial EncounterNetherlands
-
Michael MaRecruitingDifficult Intubation | Difficult Airway IntubationIreland
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntubation Complication | Intubation;Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Singapore
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)RecruitingIntubation Complication | Intubation; Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Japan, Italy, New Zealand, Singapore, Australia, Austria, Germany, India, United Kingdom
-
J. Matthias WalzTerminatedSurgery | Difficult Intubation | Anesthesia | Difficult Airway Intubation | Speech DysfunctionUnited States
-
University at BuffaloTerminatedIntubation Complication | Intubation;DifficultUnited States
-
University Hospitals Coventry and Warwickshire...Oxford University Hospitals NHS TrustCompletedIntubation;Difficult | Tracheal IntubationUnited Kingdom
-
Heinrich-Heine University, DuesseldorfCompleted
-
Derince Training and Research HospitalCompletedDifficult Intubation | Difficult AirwayTurkey
Clinical Trials on C-MAC VS
-
Alexandria UniversityActive, not recruitingEffectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal IntubationDifficult Intubation | Difficult Mask VentilationEgypt
-
University Hospital Inselspital, BerneRecruiting
-
Lawson Health Research InstituteRecruitingIntubation Complication | Intubation;DifficultCanada
-
rehab zayedActive, not recruitingDifficult Intubation | Difficult Mask VentilationEgypt
-
University Hospital Inselspital, BerneTerminated
-
Medical University of WarsawCompleted
-
The University of Texas Health Science Center,...CompletedIntubation; DifficultUnited States
-
Inonu UniversityCompletedMorbid Obesity | Difficult Intubation | VideolaryngoscopyTurkey
-
Universitätsklinikum Hamburg-EppendorfCompletedGeneral Anesthesia | Intubation; Difficult or Failed | VideolaryngoscopyGermany
-
Yonsei UniversityCompleted