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

NCT06360328 | Recruiting DMC

• 1 other identifier: 033-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation Complication; Intubation

Keywords

Airway Management; Video-Laryngoscopy; First-Pass-Success; Skill of Intubation; Direct Laryngoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma.

  Directly during intubation

• Specify the number of attempts made during laryngoscopy.

  Directly during intubation

• Compare the level of training with intubation success.

  During the analysis

• 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.

  Directly during intubation

Study Arms (2)

direct Laryngoscopy

NO INTERVENTION

The resident intubates using direct laryngoscopy .

video Laryngoscopy

EXPERIMENTAL

The resident intubates using video laryngoscopy

Device: video laryngoscopy

Interventions

video laryngoscopy DEVICE

The residents used video laryngoscopy for endotracheal intubation

video Laryngoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First Year Anesthesiology Residents

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Officials

• Davut Deniz Uzun, Dr. / MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Davut Deniz Uzun, Dr. / MD

CONTACT

004962215639349; deniz.uzun@med.uni-heidelberg.de

Felix Schmitt, Ass. Prof.

CONTACT

Felix.Schmitt@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the patient is blinded, as the participants (residents) cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Post-Doc Researcher, Department of Anesthesiology

Model Details: Control group = direct laryngoscopy Intervention group = video laryngoscopy

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)