Difficult Airway IntubationNCT04252222
The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults
A study testing Videolaryngoscopy with VL3 in people with Difficult Airway Intubation, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
We conducted an observational prospective pilot study to assess the efficacy of the VL3 videolaryngoscope for routinely tracheal intubation in 56 adults, in terms of successful rate, no. attempts and manoeuvre duration, including both normal and difficult airways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Airway Intubation
- What is being tested?
- Videolaryngoscopy with VL3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2018to 1 Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients candidates for general anesthesia in elective surgery
- Age over 18 years
- ASA physical status I-III.
Who cannot join
- Paediatric population
- ASA physical status IV
- Emergency tracheal intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults: a Prospective Pilot Study
We conducted an observational prospective pilot study to assess the efficacy of the VL3 videolaryngoscope for routinely tracheal intubation in 56 adults, in terms of successful rate, no. attempts and manoeuvre duration, including both normal and difficult airways.
- Conditions
- Difficult Airway Intubation
- Being tested
- Videolaryngoscopy with VL3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videolaryngoscopy with VL3Device
Tracheal Intubation aided by VL3 Videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| VL3 | Experimental | Tracheal intubation with VL3 videolaryngoscope Receives: Device: Videolaryngoscopy with VL3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal intubation rate
successful tracheal intubation rate using VL3 video laryngoscope
Measured: 30 minutes
Number of attempts
Number of attempts for a successful tracheal intubation
Measured: 30 minutes
Total time of intubation
Time needed to perform a tracheal intubation from the insertion of VL3 video laryngoscope into the patient mouth
Measured: 15 minutes
Time to glottis visualization
Time needed to visualize the glottis from the insertion of VL3 video laryngoscope into the patient mouth
Measured: 15 minutes
Cormack-Lehane grade
Cormack-Lehane grade observed at videolaryngoscopy
Measured: 15 minutes
Secondary outcomes (2)
Need for external laryngeal pressure
Need for external laryngeal pressure during laryngoscopy
Measured: 15 minutes
Presence of post-laryngoscopy side effects
Presence of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start4 Dec 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway IntubationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Pascarella, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252222
- Sponsor's protocol ID
- 82/18 OSS ComET CBM
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04252222
- Acronym / sponsor ID
- 82/18 OSS ComET CBM
- Conditions
- Difficult Airway Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 5 Feb 2020 (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.
We conducted an observational prospective pilot study to assess the efficacy of the VL3 videolaryngoscope for routinely tracheal intubation in 56 adults, in terms of successful rate, no. attempts and manoeuvre duration, including both normal and difficult airways.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VL3 | Experimental | Device: Videolaryngoscopy with VL3Tracheal intubation with VL3 videolaryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients candidates for general anesthesia in elective surgery
- Age over 18 years
- ASA physical status I-III.
Key exclusion criteria (3 listed)
- Paediatric population
- ASA physical status IV
- Emergency tracheal intubation
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 |
|---|---|---|
| Videolaryngoscopy with VL3Tracheal Intubation aided by VL3 Videolaryngoscope | Device | VL3 |
Primary outcome
Tracheal intubation rate
Time frame: 30 minutes
successful tracheal intubation rate using VL3 video laryngoscope
Number of attempts
Time frame: 30 minutes
Number of attempts for a successful tracheal intubation
Total time of intubation
Time frame: 15 minutes
Time needed to perform a tracheal intubation from the insertion of VL3 video laryngoscope into the patient mouth
Time to glottis visualization
Time frame: 15 minutes
Time needed to visualize the glottis from the insertion of VL3 video laryngoscope into the patient mouth
Cormack-Lehane grade
Time frame: 15 minutes
Cormack-Lehane grade observed at videolaryngoscopy
2 secondary outcomes
Need for external laryngeal pressure
Time frame: 15 minutes
Presence of post-laryngoscopy side effects
Time frame: 3 days
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscopy with VL3 in people with Difficult Airway Intubation, run by Campus Bio-Medico University at 1 site in Italy.
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 3 inclusion and 3 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 5 Feb 2020. 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 Italy. 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?
Tracheal intubation rate (time frame: 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.