Intubation;DifficultNCT03742830
Awake Intubation V-MAC VS
An observational study of Intubation;Difficult, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- C-MAC VS
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Feb 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- indication for awake oral intubation
- elective surgery
- age 18-80
- written Informed Consent
- knowledge of the German language enough to understand the Informed Consent
Who cannot join
- emergency patients
- uncooperative patients
- ASA (= Physical Status Classification System) V
- study equipment and personal not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- C-MAC VS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC VSDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation success
The intubation success rate at first attempt in less than 120 seconds
Measured: 120 seconds
Secondary outcomes (12)
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)
Measured: 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
The period of time that is needed for the airway management and the respiratory security
Measured: 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
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).
Measured: On the 1st post-procedure day
Total number of intubation attempts
The total number that is needed to secure the airway with intubation
Measured: 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 weight
The weight of each patient will be presented in kilograms
Measured: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as size
The size of each patient will be presented in meter/centimeter
Measured: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as gender
The gender (female or male) will be presented
Measured: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as BMI
Weight and Height will be combined to report BMI in kg/m2
Measured: During the process of screening, up to 24 hours before the study session starts
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)
Measured: 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
The investigators will use the standard non-invasive monitoring of the University Hospital to measure the heart rate (beats per minute)
Measured: 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
The investigators will use the standard non-invasive monitoring of the University Hospital to measure the arterial oxygen saturation (SaO2 in percent)
Measured: 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
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start6 Feb 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Greif, Prof.Dr.med., Principal investigator, University Hospital of Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742830
- Sponsor's protocol ID
- 2018-01454
- Other IDs
- 2018
- Status last verified
- Jan 2020
- First submitted
- 9 Nov 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 21447488Ovassapian 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.
PubMed 11444112Falcetta 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.
PubMed 22095109
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Intubation in Difficult Airway- a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03742830
- Acronym / sponsor ID
- 2018-01454
- Conditions
- Intubation;Difficult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- indication for awake oral intubation
- elective surgery
- age 18-80
- written Informed Consent
- knowledge of the German language enough to understand the Informed Consent
Key exclusion criteria (4 listed)
- emergency patients
- uncooperative patients
- ASA (= Physical Status Classification System) V
- study equipment and personal not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-MAC VSC-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. | Device | – |
Primary outcome
Intubation success
Time frame: 120 seconds
The intubation success rate at first attempt in less than 120 seconds
12 secondary outcomes
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)
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)
Patient's comfort during intubation
Time frame: 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.
Patients demographic data such as weight
Time frame: During the process of screening, up to 24 hours before the study session starts
Patients demographic data such as size
Time frame: 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
Patients demographic data such as BMI
Time frame: 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)
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)
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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Background: PubMed 21447488Cook 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.
- Background: PubMed 11444112Ovassapian 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.
- Background: PubMed 22095109Falcetta 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.
- Individual participant dataSharing planned: Undecided
Related trials for Intubation;Difficult
Not yet recruitingObservational study
A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation
Intubation, Intratracheal, Airway Management
RecruitingObservational study
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
Awake Fiberoptic Intubation, Difficult Airway
Not yet recruitingObservational study
Modified El-Ganzouri Risk Index for Predicting Difficult Intubation in Obese Patients
Difficult Intubation, Obesity
Enrolling by invitationObservational study
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
Neoplasms, Airway Obstruction Upper
Not yet recruitingObservational study
Correlation Between Bedside Anatomical Indicators and Lifting Force and Glottic Exposure Under Different Video Laryngoscopy Techniques
Difficult Airway, Intubation, Intratracheal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Greif, Prof.Dr.med. principal investigator
University Hospital of Bern, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation;Difficult, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation success (time frame: 120 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03742830, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.