Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03856398
Study type Observational
Source University Hospital Inselspital, Berne
Contact
Status Terminated
Phase
Start date March 1, 2019
Completion date December 30, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05717907 - Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia N/A
Completed NCT03653910 - Effect-site Concentration of Remifentanil for Double-lumen Tubes Intubation: Airtraq VS Macintosh Laryngoscope N/A
Recruiting NCT04190524 - Sonographic Assessment of Cricoid Pressure N/A
Completed NCT02359370 - The Effects of Lidocaine and Magnesium Sulphate on the Attenuation of the Hemodynamic Response to Tracheal Intubation Phase 4
Not yet recruiting NCT05036460 - Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients N/A
Completed NCT03992950 - Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus N/A
Completed NCT05502120 - A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese. N/A
Completed NCT05303948 - Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness N/A
Completed NCT03720093 - Exploratory Analysis of Pulmonary Microbiome in Intubated Patients
Recruiting NCT03031808 - Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant on Sore Throat and Hemodynamics Phase 4
Not yet recruiting NCT02918526 - Hemodynamic Study With PRAM of the Cardiovascular Response to the Positioning of the Extraglottic Device N/A
Completed NCT02364622 - The Effects of Flexible Intubating Stylet in the Accurate Placement of Double-lumen Endobronchial Tube N/A
Completed NCT05249738 - Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients
Terminated NCT03340207 - Novel Airway Device to Aid Endotracheal Intubations N/A
Completed NCT03842306 - End-tidal Oxygen Can Reliably Predict the Arterial Partial Pressure of Oxygen Among Emergency Department Patients
Recruiting NCT05782517 - I-gel vs. Endotracheal Intubation for Laparoscopic Gynaecological Procedures N/A
Recruiting NCT06085326 - Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study N/A
Active, not recruiting NCT06108271 - Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury N/A
Completed NCT05668299 - Determining the Appropriate Setting of an Automated Secretion Removal Technology (TrachFlush) N/A
Completed NCT04079387 - Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone N/A