Intubation ComplicationNCT03856398
C-MAC VS Clinical Observation
An observational study of Intubation Complication, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- C- MAC VS
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2019to 30 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing general anaesthesia for elective procedures at the Bern University Hospital will be screened using the Anesthesia Information System (AIS). Patients that meet the inclusion criteria, we will visited to confirm that and the given general consent.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bern University Hospital and University of Bern
Bern, 3011
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Intubation Complication
- 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.
First-attempt oro-tracheal intubation success rate in percentage
Rate of a successful intubation at first attempt
Measured: 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)
Secondary outcomes (11)
Overall success rate
The overall rate of successful intubation.
Measured: Intraoperative (The study will end when the tracheal tube is placed properly and the airway is secured.)
Number of attempts
The total number of attempts needed for the intubation in each study session
Measured: Intraoperative (Starts when the device is inserted in the patients mouth and ends when the airway is secured.)
Difficulty of intubation
It can range from very easy to very difficult
Measured: Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds
Preferred method used to lift the tongue ventral to increase space in the oral cavity and the approach
The method can include using finger, laryngoscope, spatula or other. A medial, retromolar right side and retromolar left side approach can be performed.
Measured: The beginning of the intubation procedure, when the device is inserted in the patients mouth. Estimated time 120 seconds
Tube size used
Variations of tube sizes that will be used. It is chosen because of the patients size.
Measured: Baseline
Time of the intubation procedure
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.
Measured: Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds
Intubation interim times
Interim times until the device is completely out of tube
Measured: The interim times need to be as short as possible. The estimated time for intubation: 120 seconds.
An alternative method to establish a patent airway
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.
Measured: Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time for intubation: 120 seconds
Possible problems with C-MAC VS
Adverse Events, technical problems with the device
Measured: 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
Complications during intubation
For example bleeding, laryngospasm, edema, swelling and other can be complications during intubation.
Measured: Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds
Airway ratings (Cormack- Lehane and POGO)
Cormack- and Lehane is used to classify the laryngeal view, POGO stands for percentage of glottic opening
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Mar 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Why it stopped: not sufficient enrolment possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 10 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., MD, Principal investigator, Department of Anaesthesiology and Pain Therapy, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856398
- Sponsor's protocol ID
- 2018-01452
- Other IDs
- 2018
- Status last verified
- May 2022
- First submitted
- 9 Nov 2018
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
PubMed 15271750Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology. 2005 Jul;103(1):33-9. doi: 10.1097/00000542-200507000-00009.
PubMed 15983454Williams KN, Carli F, Cormack RS. Unexpected, difficult laryngoscopy: a prospective survey in routine general surgery. Br J Anaesth. 1991 Jan;66(1):38-44. doi: 10.1093/bja/66.1.38.
PubMed 1997057Maassen R, Lee R, van Zundert A, Cooper R. The videolaryngoscope is less traumatic than the classic laryngoscope for a difficult airway in an obese patient. J Anesth. 2009;23(3):445-8. doi: 10.1007/s00540-009-0780-1. Epub 2009 Aug 14.
PubMed 19685133Choi JW, Kim JA, Jung HJ, Kim WH. Tracheal Intubation with a McGrath(R) Series 5 Video Laryngoscope by Novice Personnel in a Cervical-immobilized Manikin. J Emerg Med. 2016 Jan;50(1):61-6. doi: 10.1016/j.jemermed.2015.06.079. Epub 2015 Oct 1.
PubMed 26432080Burdett E, Ross-Anderson DJ, Makepeace J, Bassett PA, Clarke SG, Mitchell V. Randomized controlled trial of the A.P. Advance, McGrath, and Macintosh laryngoscopes in normal and difficult intubation scenarios: a manikin study. Br J Anaesth. 2011 Dec;107(6):983-8. doi: 10.1093/bja/aer295. Epub 2011 Sep 22.
PubMed 21940397Kory P, Guevarra K, Mathew JP, Hegde A, Mayo PH. The impact of video laryngoscopy use during urgent endotracheal intubation in the critically ill. Anesth Analg. 2013 Jul;117(1):144-9. doi: 10.1213/ANE.0b013e3182917f2a. Epub 2013 May 17.
PubMed 23687228
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03856398
- Acronym / sponsor ID
- 2018-01452
- Conditions
- Intubation Complication
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not sufficient enrolment possible
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 27 Feb 2019 (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.
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.
Detailed description
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing general anaesthesia for elective procedures at the Bern University Hospital will be screened using the Anesthesia Information System (AIS). Patients that meet the inclusion criteria, we will visited to confirm that and the given general consent.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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
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
11 secondary outcomes
Overall success rate
Time frame: Intraoperative (The study will end when the tracheal tube is placed properly and the airway is secured.)
Number of attempts
Time frame: Intraoperative (Starts when the device is inserted in the patients mouth and ends when the airway is secured.)
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
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
Tube size used
Time frame: Baseline
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
Intubation interim times
Time frame: The interim times need to be as short as possible. The estimated time for intubation: 120 seconds.
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
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
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
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
Results and safety
The study was stopped early (reason given: not sufficient enrolment possible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Background: PubMed 15271750Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
- Background: PubMed 15983454Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology. 2005 Jul;103(1):33-9. doi: 10.1097/00000542-200507000-00009.
- Background: PubMed 1997057Williams KN, Carli F, Cormack RS. Unexpected, difficult laryngoscopy: a prospective survey in routine general surgery. Br J Anaesth. 1991 Jan;66(1):38-44. doi: 10.1093/bja/66.1.38.
- Background: PubMed 19685133Maassen R, Lee R, van Zundert A, Cooper R. The videolaryngoscope is less traumatic than the classic laryngoscope for a difficult airway in an obese patient. J Anesth. 2009;23(3):445-8. doi: 10.1007/s00540-009-0780-1. Epub 2009 Aug 14.
- Background: PubMed 26432080Choi JW, Kim JA, Jung HJ, Kim WH. Tracheal Intubation with a McGrath(R) Series 5 Video Laryngoscope by Novice Personnel in a Cervical-immobilized Manikin. J Emerg Med. 2016 Jan;50(1):61-6. doi: 10.1016/j.jemermed.2015.06.079. Epub 2015 Oct 1.
- Background: PubMed 21940397Burdett E, Ross-Anderson DJ, Makepeace J, Bassett PA, Clarke SG, Mitchell V. Randomized controlled trial of the A.P. Advance, McGrath, and Macintosh laryngoscopes in normal and difficult intubation scenarios: a manikin study. Br J Anaesth. 2011 Dec;107(6):983-8. doi: 10.1093/bja/aer295. Epub 2011 Sep 22.
- Background: PubMed 23687228Kory P, Guevarra K, Mathew JP, Hegde A, Mayo PH. The impact of video laryngoscopy use during urgent endotracheal intubation in the critically ill. Anesth Analg. 2013 Jul;117(1):144-9. doi: 10.1213/ANE.0b013e3182917f2a. Epub 2013 May 17.
- Individual participant dataSharing planned: Undecided
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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., MD principal investigator
Department of Anaesthesiology and Pain Therapy, Bern University Hospital
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 Complication, 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 Jun 2022. 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 was stopped early (reason given: not sufficient enrolment possible). Results are not available in the source record.
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?
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)). 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 NCT03856398, which also lists 7 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 2 Jun 2022.