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Recruiting NCT06360328

Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial)

No phase Interventional Intubation Complication Intubation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: video laryngoscopy.
Who it may be relevant to
Registry conditions: Intubation Complication, Intubation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device video laryngoscopy
    The residents used video laryngoscopy for endotracheal intubation

Primary outcome measures

  • Rate of Successful tracheal intubation on the first attempt (First-Pass-Success). [Time frame: Directly during intubation]
Secondary outcome measures (8)
  • Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma. [Time frame: Directly during intubation]
  • Specify the number of attempts made during laryngoscopy. [Time frame: Directly during intubation]
  • Compare the level of training with intubation success. [Time frame: During the analysis]
  • Mention any failures or transitions to other rescue techniques. [Time frame: Directly during intubation]
  • 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. [Time frame: Directly during intubation]
  • When using VL, record the occurrence of fogging. [Time frame: Directly during intubation]
  • Assess the glottic view using the Cormack-Lehane-Score (I - IV). (I = good view) [Time frame: Directly during intubation]
  • assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%). (0%= no view, 100% best view) [Time frame: Directly during intubation]

Eligibility criteria

Inclusion criteria

  • First Year Anesthesiology Residents

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University, — Heidelberg

Publications

  • Uzun DD, Eicher S, Mohr S, Weigand MA, Schmitt FCF. Success rates of video vs. direct laryngoscopy for endotracheal intubation in anesthesiology residents: a study protocol for a randomized controlled trial (JuniorDoc-VL-Trial). Trials. 2025 Feb 27;26(1):75. doi: 10.1186/s13063-025-08785-y. PMID 40016759

Identifiers

NCT: NCT06360328 · 033-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗