Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360328
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-08
Brief Title:
Success Rates of Video- vs Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents A Randomized Controlled Trial The JuniorDoc-VL-Trial
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Success Rates of Video- vs Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents A Randomized Controlled Trial The JuniorDoc-VL-Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JuniorDoc-VL
Brief Summary:
Securing the airway through endotracheal intubation ETI is a fundamental skill for anaesthetists It is used during surgery in the intensive care unit during periprocedural anaesthesia and in emergency medicine The clinical relevance of airway management is demonstrated in particular by the fact that the main cause of serious anaesthesia-related complications lies in the area of airway management increasing technological developments in recent years eg video laryngoscopy VL aim to reduce the complication rate in the area of airway management however there are currently a large number of VLs available which differ massively in their application Therefore it is essential to systematically collect data and develop structured training in airway management taking into account current technological developmentsWhile endotracheal intubation is traditionally performed with a direct laryngoscope indirect video laryngoscopy with chip-based camera technology at its tip has been introduced across the board in recent years and is now part of standard clinical and preclinical equipment Doctors in advanced training are trained with a focus on direct laryngoscopy the use of and training in indirect video laryngoscopy does not follow any standards in addition the decision as to which method of securing the airway is chosen has so far been the responsibility of the individual doctor in anaesthesiology although there is a tendency for the VL to be associated with a higher success rate in the first intubation attempt the so-called first-pass successThe main aim of this clinical prospective randomised controlled trial is to train anaesthetists in advanced training in conventional direct laryngoscopy on the one hand and indirect video laryngoscopy VL on the other with a focus on tracking the progress of their skills after 200 intubations with regard to first-pass success
Detailed Description:
Securing the airway is a core competence of anaesthetists intensive care physicians and emergency physicians as oxygenation of the human organism is not possible without an open or secured airway The introduction of new techniques and the implementation of guidelines and strategies for the care of the difficult airway have contributed significantly to a reduction in morbidity and mortality Of particular importance are problems that can occur during airway management which are referred to in anaesthesiology as the difficult airway The term difficult airway refers to problems that can occur during airway management Despite technological advances in the field of airway management such as the use of video laryngoscopes the definition of a difficult airway is still based on the traditional methods of mask ventilation and intubation using direct laryngoscopy In recent years several airway management studies suggest that the primary use of video laryngoscopes in adult patients undergoing endotracheal intubation is associated with a reduction in failed attempts and complications such as hypoxaemiaProblems during endotracheal intubation are often subsumed under the term difficult intubation without differentiating between laryngoscopy and endotracheal intubation However if indirect laryngoscopy techniques are used such as videolaryngoscopic intubation a clear distinction must be made between the two procedures as the incidence of difficult laryngoscopy is always lower than that of difficult or impossible intubation The incidence of difficult direct laryngoscopy is 15 to 80 while the incidence of difficult intubation is slightly lower A potentially life threatening unexpected cannot intubate cannot ventilate situation has a probability of0008 113000 to 0004 125000 In a randomised study design we would like to record resident anaesthesiologists first-year learning the skill of endotracheal intubation with direct and indirect laryngoscopy in order to derive and analyse anaesthesiological quality parameters such as first-pass success and possible complications The individual learning curves of those entering the profession will also be taken into account in order to gain insights for the improvement of training programmes and training methods in anaesthesiology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None