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

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.

Study Overview

• Status: Recruiting
• Conditions: Intubation; Intubation Complication
• Intervention / Treatment: Device: video laryngoscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Davut Deniz Uzun, Dr. / MD; Phone Number: 004962215639349; Email: deniz.uzun@med.uni-heidelberg.de
• Study Contact Backup: Name: Felix Schmitt, Ass. Prof.; Email: Felix.Schmitt@med.uni-heidelberg.de

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Recruiting
      • Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,
      • Contact: Davut Deniz Uzun, MD; Phone Number: 0049 62215639349; Email: deniz.uzun@med.uni-heidelberg.de
      • Contact: Felix Schmitt, MD; Phone Number: 0049 62215639421; Email: Felix.Schmitt@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• First Year Anesthesiology Residents

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: direct Laryngoscopy; The resident intubates using direct laryngoscopy .
Experimental: video Laryngoscopy; The resident intubates using video laryngoscopy	Device: video laryngoscopy; The residents used video laryngoscopy for endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).	Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).	Directly during intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specify the number of attempts made during laryngoscopy.	Specify the number of attempts made during laryngoscopy.	Directly during intubation
Compare the level of training with intubation success.	Compare the level of training with intubation success.	During the analysis
Mention any failures or transitions to other rescue techniques.	Mention any failures or transitions to other rescue techniques.	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.	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.	Directly during intubation
When using VL, record the occurrence of fogging.	When using VL, record the occurrence of fogging.	Directly during intubation
Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma.	Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma.	Directly during intubation
Assess the glottic view using the Cormack-Lehane-Score (I - IV). (I = good view)	Assess the glottic view using the Cormack-Lehane-Score (I - IV).(I = good view)	Directly during intubation
assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%). (0%= no view, 100% best view)	assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%)(0%= no view, 100% best view)	Directly during intubation

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Davut Deniz Uzun, Dr. / MD, University of Heidelberg, Medical Faculty, Departement of Anesthesiology, Heidelberg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 18, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Airway Management; Direct Laryngoscopy; Video-Laryngoscopy; First-Pass-Success; Skill of Intubation
• Other Study ID Numbers: 033-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No