Clinical trial NCT06360328: Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial)
Official title: Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intubation Complication
Intubation
Keywords: Airway Management
Video-Laryngoscopy
First-Pass-Success
Skill of Intubation
Direct Laryngoscopy
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group = direct laryngoscopy Intervention group = video laryngoscopy
Primary purpose: TREATMENT

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 (e.g. 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 developments.While 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 success".The 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 hypoxaemia.Problems 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 1.5% to 8.0%, while the incidence of difficult intubation is slightly lower. A potentially life threatening unexpected "cannot intubate, cannot ventilate" situation has a probability of0.008% (1:13,000) to 0.004% (1:25,000). 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.

Eligibility criteria: Inclusion Criteria:

* First Year Anesthesiology Residents

Exclusion Criteria:

* Physicians' refusal to participate in the study
* Participants in another study

Primary outcomes:
measure: Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).
timeFrame: Directly during intubation
Secondary outcomes:
measure: Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma.
timeFrame: Directly during intubation
measure: Specify the number of attempts made during laryngoscopy.
timeFrame: Directly during intubation
measure: Compare the level of training with intubation success.
timeFrame: During the analysis
measure: Mention any failures or transitions to other rescue techniques.
timeFrame: Directly during intubation
measure: Specify the use of Optimal External Laryngeal Manipulation (OELM) techniques such as backward, upward and rightward pressure (BURP) Cricoid Pressure (CP) or adjustment of the participant's head and neck position.
timeFrame: Directly during intubation
measure: When using VL, record the occurrence of fogging.
timeFrame: Directly during intubation
measure: Assess the glottic view using the Cormack-Lehane-Score (I - IV). (I = good view)
timeFrame: Directly during intubation
measure: assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%). (0%= no view, 100% best view)
timeFrame: Directly during intubation
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,
state: Baden-Wuerttemberg
Study officials:
affiliation: University of Heidelberg, Medical Faculty, Departement of Anesthesiology, Heidelberg, Germany
name: Davut Deniz Uzun, Dr. / MD
role: PRINCIPAL_INVESTIGATOR
References: