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

NCT ID: NCT06360328

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-08-01

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.

Conditions

Intubation Complication; Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

direct Laryngoscopy

The resident intubates using direct laryngoscopy .

Group Type: NO_INTERVENTION

No interventions assigned to this group

video Laryngoscopy

The resident intubates using video laryngoscopy

Group Type: EXPERIMENTAL

video laryngoscopy

Intervention Type: DEVICE

The residents used video laryngoscopy for endotracheal intubation

Interventions

video laryngoscopy

The residents used video laryngoscopy for endotracheal intubation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• First Year Anesthesiology Residents

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Davut Deniz Uzun

Medical Doctor, Post-Doc Researcher, Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davut Deniz Uzun, Dr. / MD

Role: PRINCIPAL_INVESTIGATOR

University of Heidelberg, Medical Faculty, Departement of Anesthesiology, Heidelberg, Germany

Locations

Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Davut Deniz Uzun, Dr. / MD

Role: CONTACT

deniz.uzun@med.uni-heidelberg.de

004962215639349

Felix Schmitt, Ass. Prof.

Role: CONTACT

Felix.Schmitt@med.uni-heidelberg.de

Facility Contacts

Davut Deniz Uzun, MD

Role: primary

deniz.uzun@med.uni-heidelberg.de

0049 62215639349

Felix Schmitt, MD

Role: backup

Felix.Schmitt@med.uni-heidelberg.de

0049 62215639421

References

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.

Reference Type: DERIVED

PMID: 40016759 (View on PubMed)

Other Identifiers

033-2024

Identifier Type: -

Identifier Source: org_study_id