Intubation ComplicationJuniorDoc-VLNCT06360328
Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial)
A study testing video laryngoscopy in people with Intubation Complication and Intubation, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication, Intubation
- What is being tested?
- video laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First Year Anesthesiology Residents
Who cannot join
- Physicians' refusal to participate in the study
- Participants in another study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Felix Schmitt, Ass. Prof. contact
Germany1 site, 1 recruiting
- Recruiting
Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,
Heidelberg, Baden-Wurttemberg, 69120
Davut Deniz Uzun, MD, 0049 62215639349, deniz.uzun@med.uni-heidelberg.de
Felix Schmitt, MD, 0049 62215639421, Felix.Schmitt@med.uni-heidelberg.de
About this study
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.
Read the 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
- Being tested
- video laryngoscopy
- Keywords
- Airway Management, Video-Laryngoscopy, First-Pass-Success, Skill of Intubation, Direct Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video laryngoscopyDevice
The residents used video laryngoscopy for endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| direct Laryngoscopy | No intervention | The resident intubates using direct laryngoscopy . |
| video Laryngoscopy | Experimental | The resident intubates using video laryngoscopy Receives: Device: video laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).
Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).
Measured: Directly during intubation
Secondary outcomes (8)
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.
Measured: Directly during intubation
Specify the number of attempts made during laryngoscopy.
Specify the number of attempts made during laryngoscopy.
Measured: Directly during intubation
Compare the level of training with intubation success.
Compare the level of training with intubation success.
Measured: During the analysis
Mention any failures or transitions to other rescue techniques.
Mention any failures or transitions to other rescue techniques.
Measured: 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.
Measured: Directly during intubation
When using VL, record the occurrence of fogging.
When using VL, record the occurrence of fogging.
Measured: 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)
Measured: 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)
Measured: Directly during intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group = direct laryngoscopy Intervention group = video laryngoscopy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Davut Deniz Uzun, University Hospital Heidelberg
- Investigators
- Davut Deniz Uzun, Dr. / MD, Principal investigator, University of Heidelberg, Medical Faculty, Departement of Anesthesiology, Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360328
- Sponsor's protocol ID
- 033-2024
- Acronym
- JuniorDoc-VL
- Status last verified
- Jan 2025
- First submitted
- 8 Apr 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40016759
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial)
- ClinicalTrials.gov ID
- NCT06360328
- Acronym / sponsor ID
- JuniorDoc-VL / 033-2024
- Conditions
- Intubation Complication, Intubation
- Keywords
- Airway Management, Video-Laryngoscopy, First-Pass-Success, Skill of Intubation, Direct Laryngoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Control group = direct laryngoscopy Intervention group = video laryngoscopy
| Arm | Type | Receives |
|---|---|---|
| direct Laryngoscopy | No intervention | –The resident intubates using direct laryngoscopy . |
| video Laryngoscopy | Experimental | Device: video laryngoscopyThe resident intubates using video laryngoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First Year Anesthesiology Residents
Key exclusion criteria (2 listed)
- Physicians' refusal to participate in the study
- Participants in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video laryngoscopyThe residents used video laryngoscopy for endotracheal intubation | Device | video Laryngoscopy |
Primary outcome
Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).
Time frame: Directly during intubation
Rate of Successful tracheal intubation on the first attempt (First-Pass-Success).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 40016759Uzun 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.
- Individual participant dataSharing planned: No
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felix Schmitt, Ass. Prof. contact
Davut Deniz Uzun, Dr. / MD principal investigator
University of Heidelberg, Medical Faculty, Departement of Anesthesiology, Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video laryngoscopy in people with Intubation Complication and Intubation, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davut Deniz Uzun, Dr. / MD (004962215639349, deniz.uzun@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Successful tracheal intubation on the first attempt (First-Pass-Success). (time frame: Directly during intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06360328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.