Tracheal IntubationNCT06918717
Prehospital Tracheal Intubation Technique Using Initial Direct Laryngoscopy During Videolaryngoscopy
A study testing Direct Laryngoscopy-to-VideoLaryngoscopy sequence and Free use of videolaryngoscopy in people with Tracheal Intubation, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Tracheal intubation using videolaryngoscopy may be required in the prehospital setting, where airway management presents unique technical and logistical challenges. Intubation may be hard because novice providers performing videolaryngoscopy may only look at the screen and only obtain a two-dimensional representation… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Direct Laryngoscopy-to-VideoLaryngoscopy sequence and Free use of videolaryngoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Sep 2023to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All resident physicians with 1 to 6 years of post-graduate experience working in the Emergency Department (ED) at Geneva University Hospitals (Hôpitaux Universitaires de Genève (HUG)) and penultimate year of medical school students (5th year) studying at University of Geneva Faculty of Medicine (UGFM).
- Performed less than 10 ETIs prior to participating in the study.
Who cannot join
- More than 6 years of post-graduate experience
- Performed more than 10 ETIs prior to participating in the study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 1205
About this study
Official title: Assessment of Prehospital Tracheal Intubation Technique Using Initial Direct Laryngoscopy During Videolaryngoscopy: Randomized Controlled Simulated Trial
Tracheal intubation using videolaryngoscopy may be required in the prehospital setting, where airway management presents unique technical and logistical challenges. Intubation may be hard because novice providers performing videolaryngoscopy may only look at the screen and only obtain a two-dimensional representation of the patient's airways. By directly visualizing the airways, these providers may obtain a better 3D apprehension and an improved mental visualization of the patient's anatomy. We aim to compare the impact of a freely realized videolaryngoscopy sequence with a sequence consisting in direct visualization of the airway followed by videolaryngoscopy ("Direct Laryngoscopy-to-VideoLaryngoscopy sequence" or "DL-VL sequence") on time to intubation among novice providers.
- Conditions
- Tracheal Intubation
- Being tested
- Direct Laryngoscopy-to-VideoLaryngoscopy sequence, Free use of videolaryngoscopy
- Keywords
- Advanced airway management, direct laryngoscopy, tracheal intubation, prehospital, videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Laryngoscopy-to-VideoLaryngoscopy sequenceProcedure or surgery
Participants will proceed with a double intubation technique sequence, first performing an initial direct laryngoscopy without looking at the video screen until they reached the epiglottis, then performing an indirect lryngoscopy for intubation.
Free use of videolaryngoscopyProcedure or surgery
Participants are free to use of the videolaryngoscope as they intended
| Study group | Role | What they receive |
|---|---|---|
| Free use of videolaryngoscopy | Active comparator | Not described Receives: Procedure: Free use of videolaryngoscopy |
| Direct Laryngoscopy-to-VideoLaryngoscopy sequence | Experimental | Not described Receives: Procedure: Direct Laryngoscopy-to-VideoLaryngoscopy sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation
Time in seconds from blade insertion at the dental arch to adequate tracheal tube placement through the vocal cords, confirmed by the C-MAC video recording. A maximum of 60 seconds was allowed per ETI attempt. The maximum number of ETI attempts was limited to 3.
Measured: Periprocedural
Secondary outcomes (5)
Time to Intubation for the first intubation attempt alone
Time in seconds from blade insertion at the dental arch to adequate tracheal tube placement through the vocal cords, confirmed by the C-MAC video recording. A maximum of 60 seconds was allowed per ETI attempt.
Measured: Periprocedural
First Pass Success rate
Intubation first pass success rate, in percentage.
Measured: Periprocedural
Number of intubations attempts
An ETI attempt was defined as the insertion of the laryngoscope blade at the dental arch, regardless of whether tracheal tube placement was attempted. A maximum of 60 seconds was allowed per ETI attempt. The maximum number of ETI attempts was limited to 3. More than 3 attempts, it was considered as failed.
Measured: Periprocedural
Time to Ventilation
Time in seconds from blade insertion at the dental arch to successful ventilation confirmed by chest elevation. A maximum of 60 seconds was allowed per ETI attempt.
Measured: Periprocedural
Subjective assessments
Subjective assessments, including perceived difficulty (Question 1 - I found intubation easy. Question 2 - I felt comfortable intubating this way. Question 3 - I think the use of the VL was adequate to intubate OR I think the sequenced use of the VL helped me intubate. Question 4 - In a future similar clinical situation, I will make the same use of the VL to intubate OR I think doing a direct laryngoscopy before looking at the screen allows for faster intubation than doing an indirect laryngoscopy only. Question 5 - In a future similar clinical situation, I will make a different use of the VL to intubate OR In a future similar clinical situation, I will make the same use (DL-VL) of the VL to intubate. Question 6 - In a future similar clinical situation, I will make a different use (VL only) of the VL to intubate.), were appraised using a 5-point Likert scale ranging from "Totally Agree" to "Totally Disagree".
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start10 Sep 2023
- Primary completion20 Apr 2024
- Study completion15 Aug 2024
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 Tracheal IntubationStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cédric Cibotto, University Hospital, Geneva
- Investigators
- PD Dr Laurent Suppan, Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918717
- Sponsor's protocol ID
- Req-2023-00073
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cibotto C, Pasquier M, Beysard N, Rouyer F, Grosgurin O, Bourgeois L, Erriquez E, Braun E, Gartner BA, Desmettre T, Suppan L. Assessment of prehospital tracheal intubation technique using initial direct laryngoscopy during videolaryngoscopy: randomized controlled simulated trial. BMC Emerg Med. 2025 Jul 1;25(1):112. doi: 10.1186/s12873-025-01266-0.
PubMed 40596822
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prehospital Tracheal Intubation Technique Using Initial Direct Laryngoscopy During Videolaryngoscopy: Randomized Controlled Simulated Trial
- ClinicalTrials.gov ID
- NCT06918717
- Acronym / sponsor ID
- Req-2023-00073
- Conditions
- Tracheal Intubation
- Keywords
- Advanced airway management, direct laryngoscopy, tracheal intubation, prehospital, videolaryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 9 Apr 2025 (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.
Tracheal intubation using videolaryngoscopy may be required in the prehospital setting, where airway management presents unique technical and logistical challenges. Intubation may be hard because novice providers performing videolaryngoscopy may only look at the screen and only obtain a two-dimensional representation of the patient's airways. By directly visualizing the airways, these providers may obtain a better 3D apprehension and an improved mental visualization of the patient's anatomy. We aim to compare the impact of a freely realized videolaryngoscopy sequence with a sequence consisting in direct visualization of the airway followed by videolaryngoscopy ("Direct Laryngoscopy-to-VideoLaryngoscopy sequence" or "DL-VL sequence") on time to intubation among novice providers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free use of videolaryngoscopy | Active comparator | Procedure: Free use of videolaryngoscopy |
| Direct Laryngoscopy-to-VideoLaryngoscopy sequence | Experimental | Procedure: Direct Laryngoscopy-to-VideoLaryngoscopy sequence |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All resident physicians with 1 to 6 years of post-graduate experience working in the Emergency Department (ED) at Geneva University Hospitals (Hôpitaux Universitaires de Genève (HUG)) and penultimate year of medical school students (5th year) studying at University of Geneva Faculty of Medicine (UGFM).
- Performed less than 10 ETIs prior to participating in the study.
Key exclusion criteria (2 listed)
- More than 6 years of post-graduate experience
- Performed more than 10 ETIs prior to participating in the 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 |
|---|---|---|
| Direct Laryngoscopy-to-VideoLaryngoscopy sequenceParticipants will proceed with a double intubation technique sequence, first performing an initial direct laryngoscopy without looking at the video screen until they reached the epiglottis, then performing an indirect lryngoscopy for intubation. | Procedure or surgery | Direct Laryngoscopy-to-VideoLaryngoscopy sequence |
| Free use of videolaryngoscopyParticipants are free to use of the videolaryngoscope as they intended | Procedure or surgery | Free use of videolaryngoscopy |
Primary outcome
Time to Intubation
Time frame: Periprocedural
Time in seconds from blade insertion at the dental arch to adequate tracheal tube placement through the vocal cords, confirmed by the C-MAC video recording. A maximum of 60 seconds was allowed per ETI attempt. The maximum number of ETI attempts was limited to 3.
5 secondary outcomes
Time to Intubation for the first intubation attempt alone
Time frame: Periprocedural
First Pass Success rate
Time frame: Periprocedural
Number of intubations attempts
Time frame: Periprocedural
Time to Ventilation
Time frame: Periprocedural
Subjective assessments
Time frame: Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Derived from this study: PubMed 40596822Cibotto C, Pasquier M, Beysard N, Rouyer F, Grosgurin O, Bourgeois L, Erriquez E, Braun E, Gartner BA, Desmettre T, Suppan L. Assessment of prehospital tracheal intubation technique using initial direct laryngoscopy during videolaryngoscopy: randomized controlled simulated trial. BMC Emerg Med. 2025 Jul 1;25(1):112. doi: 10.1186/s12873-025-01266-0.
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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. This study is not recruiting at the moment.
PD Dr Laurent Suppan study director
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Laryngoscopy-to-VideoLaryngoscopy sequence and Free use of videolaryngoscopy in people with Tracheal Intubation, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 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: finished, as of the sponsor's last update on 9 Apr 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Intubation (time frame: Periprocedural). 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 NCT06918717, 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 9 Apr 2025.