One Lung VentilationVOLCANONCT06466759
Videolaryngoscopy vs Direct Laryngoscopy for Double Lumen Tube Lumen Tube Placement - A Multicentre Randomized-controlled Trial (VOLCANO Study)
A study testing Mc Grath Videolaryngoscope in people with One Lung Ventilation and Intubation Complication, run by Luca Brazzi.
Trial summary
The general aim of the study is to observe whether the use of the Mc Grath™ videolaryngoscope instead of direct laryngoscopy can represent, as in the case of the single-lumen tube, an added value in the placement of the double-lumen tube for surgical procedures involving one-lung ventilation, making intubation on the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- One Lung Ventilation, Intubation Complication
- What is being tested?
- Mc Grath Videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2024to 31 Dec 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- General anesthesia
- One-lung ventilation via double-lumen tube
Who cannot join
- Patients who refuse to consent to participation in the study.
- Patients scheduled for awake intubation due to pre-operative evaluation findings of predictors of difficult oxygenation that contraindicate intubation under general anesthesia.
- Patients with anatomical anomalies leading to tracheal and/or laryngeal displacement/compression.
- Patients with contraindications to double-lumen tube placement.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: VideolaryngOscopy With Mc Grath™ vs Direct LaryngosCopy for the Positioning of A Double lumeN endOtracheal Tube (VOLCANO Study)
The general aim of the study is to observe whether the use of the Mc Grath™ videolaryngoscope instead of direct laryngoscopy can represent, as in the case of the single-lumen tube, an added value in the placement of the double-lumen tube for surgical procedures involving one-lung ventilation, making intubation on the first attempt more likely and quicker. Secondary objectives include evaluating the presence of an advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for the correct placement of the double-lumen tube, the need for additional maneuvers during the intubation procedure, and the presence of intra- and post-procedural complications.
Read the detailed description
Placement of the double-lumen tube (DLT) can be more challenging because the endobronchial tube is larger (thus worsening glottic view) and more rigid (increasing the risk of trauma and reducing maneuverability during placement). An anatomically easy airway can become more demanding when there's a need to place a double-lumen tube. Success rates and intubation times can vary significantly. The superiority of videolaryngoscopy (VLS) over direct laryngoscopy (DL) is clear regarding the placement of the single-lumen endotracheal tube (SLT). Its use is now "recommended" as the first attempt in anticipated difficult airways and "suggested" for all routine intubations. To date, 19 prospective randomized controlled trials have compared the effectiveness of six VLS devices for DLT intubation versus DL in patients with anticipated non-difficult airways. Key endpoints included glottic view, intubation time, success rate, intubation difficulty rating, incidence of malpositioning, postoperative sore throat, hoarseness, procedure-related complications, and intubation-related stress response. Apart from a superior glottic view with VLS compared to DL, consistent results have not emerged across different studies. This heterogeneity may be attributed to differences in the experience of the operators involved, the type of VLS used, and finally the definition of the primary endpoint. Conducting a randomized controlled study with adequate and larger sample size than previous ones and a homogeneous population can ascertain whether VLS can represent, as in the case of SLT, an added value in DLT placement, guiding clinicians towards its routine use.
It is worth noting that current guidelines on DLT intubation do NOT recommend the "1st choice" use of VLS, a recommendation already existing for SLT placement. For this reason, in clinical practice, both devices are effectively used interchangeably, largely based on individual clinician preferences, which moreover possess comparable expertise in both direct laryngoscopy and videolaryngoscopy.
Aim: To compare the effectiveness of a single videolaryngoscope, the Mc Grath™, versus direct laryngoscopy in placing the double-lumen tube in surgery.
Experimental design: Multicentric Randomized Controlled Trial Primary endpoint: evaluation of the advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for double-lumen tube intubation.
Secondary endpoints: Evaluation of the advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for intra- and post-procedural complications, need for additional maneuvers, and correct placement of the double-lumen tube.
Study duration: 24 months
- Conditions
- One Lung Ventilation, Intubation Complication
- Being tested
- Mc Grath Videolaryngoscope
- Keywords
- videolaryngoscope, double-lumen tube, one-lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mc Grath VideolaryngoscopeDevice
Use of Videolaryngoscope with Mc Grath versus direct laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| VOLCANO - double lumen tube placement with direct laryngoscopy | No intervention | Patients will receive double lumen tube placement with direct laryngoscopy |
| VOLCANO - double lumen tube placement with videolaryngoscopy | Active comparator | Patients will receive double lumen tube placement with videolaryngoscopy Receives: Device: Mc Grath Videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of partecipant with first pass intubation success
first pass intubation success of the Mc Grath™ videolaryngoscope over direct laryngoscopy for double-lumen tube intubation.
Measured: up to 1 hour
Secondary outcomes (1)
Intubation-related complications
Evaluation of the advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for intra- and post-procedural complications, need for additional maneuvers, and correct placement of the double-lumen tube.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start2 Jul 2024 (estimated)
- Primary completion2 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One Lung VentilationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luca Brazzi
- Sponsor type
- University, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza - Molinette Hospital
- Responsible party
- Sponsor-investigator, Luca Brazzi, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466759
- Sponsor's protocol ID
- 915.982
- Acronym
- VOLCANO
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VideolaryngOscopy With Mc Grath™ vs Direct LaryngosCopy for the Positioning of A Double lumeN endOtracheal Tube (VOLCANO Study)
- ClinicalTrials.gov ID
- NCT06466759
- Acronym / sponsor ID
- VOLCANO / 915.982
- Conditions
- One Lung Ventilation, Intubation Complication
- Keywords
- videolaryngoscope, double-lumen tube, one-lung ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Luca BrazziUniversity, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza - Molinette Hospital
- Study start
- 2 Jul 2024 (estimated)
- Primary completion
- 2 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jun 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.
The general aim of the study is to observe whether the use of the Mc Grath™ videolaryngoscope instead of direct laryngoscopy can represent, as in the case of the single-lumen tube, an added value in the placement of the double-lumen tube for surgical procedures involving one-lung ventilation, making intubation on the first attempt more likely and quicker. Secondary objectives include evaluating the presence of an advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for the correct placement of the double-lumen tube, the need for additional maneuvers during the intubation procedure, and the presence of intra- and post-procedural complications.
Detailed description
Placement of the double-lumen tube (DLT) can be more challenging because the endobronchial tube is larger (thus worsening glottic view) and more rigid (increasing the risk of trauma and reducing maneuverability during placement). An anatomically easy airway can become more demanding when there's a need to place a double-lumen tube. Success rates and intubation times can vary significantly. The superiority of videolaryngoscopy (VLS) over direct laryngoscopy (DL) is clear regarding the placement of the single-lumen endotracheal tube (SLT). Its use is now "recommended" as the first attempt in anticipated difficult airways and "suggested" for all routine intubations. To date, 19 prospective randomized controlled trials have compared the effectiveness of six VLS devices for DLT intubation versus DL in patients with anticipated non-difficult airways. Key endpoints included glottic view, intubation time, success rate, intubation difficulty rating, incidence of malpositioning, postoperative sore throat, hoarseness, procedure-related complications, and intubation-related stress response. Apart from a superior glottic view with VLS compared to DL, consistent results have not emerged across different studies. This heterogeneity may be attributed to differences in the experience of the operators involved, the type of VLS used, and finally the definition of the primary endpoint. Conducting a randomized controlled study with adequate and larger sample size than previous ones and a homogeneous population can ascertain whether VLS can represent, as in the case of SLT, an added value in DLT placement, guiding clinicians towards its routine use.
It is worth noting that current guidelines on DLT intubation do NOT recommend the "1st choice" use of VLS, a recommendation already existing for SLT placement. For this reason, in clinical practice, both devices are effectively used interchangeably, largely based on individual clinician preferences, which moreover possess comparable expertise in both direct laryngoscopy and videolaryngoscopy.
Aim: To compare the effectiveness of a single videolaryngoscope, the Mc Grath™, versus direct laryngoscopy in placing the double-lumen tube in surgery.
Experimental design: Multicentric Randomized Controlled Trial Primary endpoint: evaluation of the advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for double-lumen tube intubation.
Secondary endpoints: Evaluation of the advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for intra- and post-procedural complications, need for additional maneuvers, and correct placement of the double-lumen tube.
Study duration: 24 months
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VOLCANO - double lumen tube placement with direct laryngoscopy | No intervention | –Patients will receive double lumen tube placement with direct laryngoscopy |
| VOLCANO - double lumen tube placement with videolaryngoscopy | Active comparator | Device: Mc Grath VideolaryngoscopePatients will receive double lumen tube placement with videolaryngoscopy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- General anesthesia
- One-lung ventilation via double-lumen tube
Key exclusion criteria (4 listed)
- Patients who refuse to consent to participation in the study.
- Patients scheduled for awake intubation due to pre-operative evaluation findings of predictors of difficult oxygenation that contraindicate intubation under general anesthesia.
- Patients with anatomical anomalies leading to tracheal and/or laryngeal displacement/compression.
- Patients with contraindications to double-lumen tube placement.
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 |
|---|---|---|
| Mc Grath VideolaryngoscopeUse of Videolaryngoscope with Mc Grath versus direct laryngoscopy | Device | VOLCANO - double lumen tube placement with videolaryngoscopy |
Primary outcome
Number of partecipant with first pass intubation success
Time frame: up to 1 hour
first pass intubation success of the Mc Grath™ videolaryngoscope over direct laryngoscopy for double-lumen tube intubation.
1 secondary outcome
Intubation-related complications
Time frame: 24 hours
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 20 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mc Grath Videolaryngoscope in people with One Lung Ventilation and Intubation Complication, run by Luca Brazzi.
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 4 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: opening soon, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Gerardo Cortese, MD (+39 0116335505, gcortese@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of partecipant with first pass intubation success (time frame: up to 1 hour). 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 20 Jun 2024.