C-MAC VS Clinical Observation
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| ClinicalTrials.gov Identifier: NCT03856398 |
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Recruitment Status :
Recruiting
First Posted : February 27, 2019
Last Update Posted : February 3, 2021
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During orotracheal intubation failure in securing an airway can result in serious oxygenation problems.
Beside the classic laryngoscopes and fibreoptic scopes, devices with high-resolution video cameras placed in the tip of the devices, were developed and attained in daily routines. Studies and case reports reveal them to be superior in both normal and difficult intubation, especially improving the first-attempt success rate.
Latest advancements of the Bonfils fiberscope resulted in the C-MAC VS, which combines rigid and semi-rigid abilities to a rigid video stylet with a flexible tip. Because of its front positioned high-resolution camera resulting in an indirect visualization, it may also have the benefits of video laryngoscopes.
Very little data is available on larger numbers of use and the investigators do not know about rare side effects and complications with the use of the device, such as esophageal intubations. Due to its direct view and positioning on vocal cord level, the investigators expect a similar or even lower rate of endotracheal intubation, using the C-MAC VS.
The investigators therefore plan to analyze the use of the C-MAC VS regarding its efficiency and safety during airway management in everyday clinical practice. This should provide the evidence about safe use, possible risk factors, rare complications and adverse events, as well as the preferred clinical airway situations to use the C-MAC VS.
| Condition or disease | Intervention/treatment |
|---|---|
| Intubation Complication | Device: C- MAC VS |
Orotracheal intubation is a core competence in anesthesia and emergency medicine. Failure in securing an airway can result in hypoxemia, aspiration, neurologic damage, cardiovascular complications, and death. Difficult anatomic structures, upper airway abnormalities, or airway trauma bear the risk of failed intubation inability to ventilate the lungs that furthermore results in oxygenation failure.
Literature tells that the rate of unexpected difficult intubations ranges from 5 to 10%, mostly corresponding to a Cormack/Lehane grade (C&L) 3 or 4.
Beside the classic laryngoscopes and fibreoptic scopes, devices with high-resolution video cameras placed in the tip of the devices, were developed and attained in daily routines. Studies and case reports reveal them to be superior in both normal and difficult intubation, especially improving the first-attempt success rate.
Rigid fiber-optic scopes may reduce intubation time and their use may result in a higher success rate. A study with 216 Patients using the Bonfils fiberscope for airway management, showed a success rate up to 98,4. Looking at the complication rates, upper airway trauma in normal patients after direct laryngoscopy with a Macintosh blade has been reported up to 6.9% and can be reduced by using a video laryngoscope.
Latest advancements of the Bonfils fiberscope resulted in the C-MAC VS, which combines rigid and semi-rigid abilities to a rigid video stylet with a flexible tip. Because of its front positioned high-resolution camera resulting in an indirect visualization, it may also have the benefits of video laryngoscopes.
But data about this new tool is rare, because this device is recently licensed. Very little data is available on larger numbers of use and the investigators do not know about rare side effects and complications with the use of the device, such as esophageal intubations.
Due to its direct view and positioning on vocal cord level, the investigators expect a similar or even lower rate of endotracheal intubation using the C-MAC VS.
The investigators therefore plan to analyze the use of the C-MAC VS regarding its efficiency and safety during airway management in everyday clinical practice. This prospective observational trial should provide the evidence about safe use, possible risk factors, rare complications and adverse events, as well as the preferred clinical airway situations to use the C-MAC VS.
The investigators will check for given general research consent. All airway management procedures and the recorded data are daily clinical routine. No experimental intervention will take place, there is no change in usual clinical practice and therefore patient's safety will not be altered by participating in the study.
The study will end when the tracheal tube is placed properly and the airway is secured. On the day after surgery the investigators will visit the patient as usually after each anesthesia to obtain follow up data. In case of a complication the patient will be followed up until the problem is cured or solved.
| Study Type : | Observational |
| Estimated Enrollment : | 2000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | The Rigid Fiberscope With a Flexible Tip C-MAC®VS in the Real Anaesthesia World: A Clinical Observation of Intubation Success and Complications |
| Actual Study Start Date : | March 1, 2019 |
| Estimated Primary Completion Date : | December 30, 2021 |
| Estimated Study Completion Date : | December 30, 2021 |
- 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.
- First-attempt oro-tracheal intubation success rate in percentage [ Time Frame: The overall rate of successful intubation at first attempt. The study will end when the tracheal tube is placed properly and the airway is secured (the first attempt should not pass 120 seconds) ]Rate of a successful intubation at first attempt
- Overall success rate [ Time Frame: Intraoperative (The study will end when the tracheal tube is placed properly and the airway is secured.) ]The overall rate of successful intubation.
- Number of attempts [ Time Frame: Intraoperative (Starts when the device is inserted in the patients mouth and ends when the airway is secured.) ]The total number of attempts needed for the intubation in each study session
- Difficulty of intubation [ Time Frame: Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds ]It can range from very easy to very difficult
- Preferred method used to lift the tongue ventral to increase space in the oral cavity and the approach [ Time Frame: The beginning of the intubation procedure, when the device is inserted in the patients mouth. Estimated time 120 seconds ]The method can include using finger, laryngoscope, spatula or other. A medial, retromolar right side and retromolar left side approach can be performed.
- Tube size used [ Time Frame: Baseline ]Variations of tube sizes that will be used. It is chosen because of the patients size.
- Time of the intubation procedure [ Time Frame: Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds ]The procedure starts as soon as the tip of the device passes patients lips and ends when a first recording of the endtidal carbon dioxide is shown.
- Intubation interim times [ Time Frame: The interim times need to be as short as possible. The estimated time for intubation: 120 seconds. ]Interim times until the device is completely out of tube
- An alternative method to establish a patent airway [ Time Frame: Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time for intubation: 120 seconds ]If intubation is not possible with the Intubations Device C-MAC® VS Video Stylet ,a different device has to be used for intubation. Alternative device: flexible laryngoscope,C-MAC Videolaryngoskop,Macintosh or LAMA.
- Possible problems with C-MAC VS [ Time Frame: If any problems occur during the preparations or during intubation itself which starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time for intubation: 120 seconds ]Adverse Events, technical problems with the device
- Complications during intubation [ Time Frame: Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds ]For example bleeding, laryngospasm, edema, swelling and other can be complications during intubation.
- Airway ratings (Cormack- Lehane and POGO) [ Time Frame: The ratings are made during the process of intubation, so when the the device is inserted in the patients mouth and ends when the airway is secured. Estimated time for intubation: 120 seconds ]Cormack- and Lehane is used to classify the laryngeal view, POGO stands for percentage of glottic opening
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients for elective and emergency surgery who have at least one predictor for difficult airway management, which are: Mallampati score >2, mouth opening <4cm, thyromental distance <6cm, head & neck movements <90°, short neck, reduced reclination.
- Patients who signed general research consent in Switzerland.
Exclusion Criteria:
- Patients under the age of 18 years
- Personnel at the study site not available of not sufficient ted in the device.
- Expected impossible mask ventilation
- High risk of aspiration (requiring rapid sequence induction intubation)
- Intracranial surgery
- Limited knowledge of German language or refusing general consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856398
| Contact: Lorenz Theiler, Prof., MD | 0316320804 | lorenz.theiler@insel.ch |
| Switzerland | |
| Bern University Hospital and University of Bern | Recruiting |
| Bern, Switzerland, 3011 | |
| Contact: Lorenz Theiler, MD +41 (31) 632 2111 ext 7837 lorenz.theiler@insel.ch | |
| Principal Investigator: Lorenz G Theiler, MD | |
| Principal Investigator: | Robert Greif, Prof., MD | Department of Anaesthesiology and Pain Therapy, Bern University Hospital |
| Responsible Party: | University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT03856398 |
| Other Study ID Numbers: |
2018-01452 |
| First Posted: | February 27, 2019 Key Record Dates |
| Last Update Posted: | February 3, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |