Intubation ComplicationDoLViNCT06401486
DOuble-Lumen Intubation With VIdeolaryngoscopy
A study testing Videolaryngoscope and Macintosh laryngoscope in people with Intubation Complication and Intubation; Difficult or Failed, run by Hospital Clinico Universitario de Santiago at 4 sites in Spain.
Trial summary
Tracheal intubation (TI) is one of the fundamental and most recognized techniques in Anesthesiology, also essential in all units treating urgent pathology and critical patients. It involves advancing a tube through the vocal cords into the trachea to ventilate the patient. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation Complication, Intubation; Difficult or Failed, Anesthesia
- What is being tested?
- Videolaryngoscope and Macintosh laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 916 participants
- Where
- 4 sitesSpain
- Study dates
- 2 Jul 2024to 21 Oct 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Patients admitted to any of the participating hospitals in the study who are undergoing thoracic surgery.
- Need for intubation with a double-lumen tube.
Who cannot join
- Pregnant or lactating women.
- Individuals who do not have the capacity to understand their participation in the study.
- Need for tracheal intubation with a device other than videolaryngoscopy or direct laryngoscopy (fiberoptic bronchoscope, tracheostomy...).
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Complexo Hospitalario Universitario de A Coruña
A Coruña
Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela
Hospital Universitario La Fe de Valencia
Valencia
Complexo Hospitalario Universitario Vigo
Vigo
About this study
Official title: Video Versus Direct Laryngoscopy for Double-lumen Tube Tracheal Intubation in Thoracic Surgery
Tracheal intubation (TI) is one of the fundamental and most recognized techniques in Anesthesiology, also essential in all units treating urgent pathology and critical patients. It involves advancing a tube through the vocal cords into the trachea to ventilate the patient. In thoracic surgery, it is often necessary to achieve lung isolation, ventilating only one lung while the operated lung remains collapsed and immobile. To achieve this, it is common to intubate the patient with a special tube: a double-lumen tube (DLT), larger than usual because it provides two ventilation channels, one for each lung.
Tracheal intubation with a DLT presents some peculiarities: its larger size and stiffness make manipulation and orientation in the oropharynx difficult. It has a curve at its distal end (the bronchial lumen) designed to slide into the left or right main bronchus as needed. The fact that the DLT passes between the vocal cords does not ensure its proper placement and function. Therefore, DLT intubation requires practice and experience, both to slide it between the vocal cords and to position it properly.
Read more
The classic technique for DLT intubation is "Direct Laryngoscopy" (DL). A traditional laryngoscope with a Macintosh blade is used to move the upper airway structures aside to allow direct visualization of the glottis. In recent years, to facilitate tracheal intubation, different videolaryngoscopes have appeared. A videolaryngoscope is a device similar to a traditional laryngoscope that allows, thanks to an image sensor located at its end, indirect visualization of the glottis on an integrated or external screen.
There is strong evidence for the benefit of using a VL over traditional DL in single-tube intubation in adult patients. However, although the use of VL for DLT intubation is becoming more common, there are few studies with small sample sizes comparing VL to DL for DLT intubation, so the evidence of its advantages or disadvantages is of low quality. It could improve glottic exposure and the percentage of success on the first attempt, although there is a possibility of increased tube malposition incidence and delayed intubation.
Therefore, Investigators propose a prospective, multicenter, randomized study comparing the traditional Macintosh blade laryngoscope (direct laryngoscopy) with the videolaryngoscope to facilitate orotracheal intubation with double-lumen tube in patients scheduled for thoracic surgery requiring lung isolation.
Read the detailed description
The purpose of this prospective multicenter randomized study is to compare successful intubation on the first attempt with the Macintosh laryngoscope vs the videolaryngoscope for double-lumen tube tracheal intubation in thoracic surgery. Investigators hypothesize that tracheal intubation using the videolaryngoscope will improve the frequency of successful intubation on the first attempt.
- Being tested
- Videolaryngoscope, Macintosh laryngoscope
- Keywords
- videolaryngoscopy, tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopeDevice
For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.
Macintosh laryngoscopeDevice
For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope group | Active comparator | For patients assigned to the videolaryngoscope Group, the operator will use a videolaryngoscope on the first laryngoscopy attempt. Receives: Device: Videolaryngoscope |
| Macintosh laryngoscope Group | Active comparator | For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt. Receives: Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intubations with successful intubation on the first attempt
The primary outcome is defined as placement of a double lumen tube in the trachea with a single insertion of a videolaryngoscope blade into the mouth and either a single insertion of a double lumen tube into the mouth.
Measured: Duration of procedure (minutes)
Secondary outcomes (2)
Successful intubation
Successful placement of a double lumen tube in the trachea
Measured: Duration of procedure (minutes)
Incidence of "easy intubation"
Easy intubation is defined as a patient with Cormack-Lehane I-II glottic view and intubation on the first attempt.
Measured: Duration of procedure (minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start2 Jul 2024
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 916 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Taboada Muñiz, Hospital Clinico Universitario de Santiago
- Investigators
- Manuel Taboada, Ph.D., Principal investigator, Clinical University Hospital of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401486
- Sponsor's protocol ID
- DoLVi trial
- Acronym
- DoLVi
- Status last verified
- Feb 2026
- First submitted
- 2 May 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karczewska K, Bialka S, Smereka J, Cyran M, Nowak-Starz G, Chmielewski J, Pruc M, Wieczorek P, Peacock FW, Ladny JR, Szarpak L. Efficacy and Safety of Video-Laryngoscopy versus Direct Laryngoscopy for Double-Lumen Endotracheal Intubation: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Nov 25;10(23):5524. doi: 10.3390/jcm10235524.
PubMed 34884226Kim YS, Song J, Lim BG, Lee IO, Won YJ. Different classes of videoscopes and direct laryngoscopes for double-lumen tube intubation in thoracic surgery: A systematic review and network meta-analysis. PLoS One. 2020 Aug 28;15(8):e0238060. doi: 10.1371/journal.pone.0238060. eCollection 2020.
PubMed 32857788Liu TT, Li L, Wan L, Zhang CH, Yao WL. Videolaryngoscopy vs. Macintosh laryngoscopy for double-lumen tube intubation in thoracic surgery: a systematic review and meta-analysis. Anaesthesia. 2018 Aug;73(8):997-1007. doi: 10.1111/anae.14226. Epub 2018 Feb 6.
PubMed 29405258Fernandez J, Francisco C, Seoane-Pillado T, Estany-Gestal A, Vazquez O, Aguirre P, Lopez RM, Lluch A, Reparaz JR, Vilar A, Arana V, Ceresuela R, Miron P, Gonzalez A, Romero JD, Otero MT, Gonzalez M, Carballo J, Minguez L, Blanco ML, Peiteado M, Casas P, Fernandez J, Martinez-Ragues G, Rodriguez A, Lopez D, Vargas MJ, Pereira D, Cortinas J, Garcia A, Blanco M, Sandoval M, Bolon A, Suarez P, Argente P, Lamas A, Ferreiroa E, Vilela M, Taboada M. Videolaryngoscopy versus direct laryngoscopy for double-lumen tube intubation: the DOuble-Lumen intubation with VIdeolaryngoscopy (DOLVI) multicentre randomised trial. Br J Anaesth. 2026 Jul;137(1):254-263. doi: 10.1016/j.bja.2026.02.048. Epub 2026 Apr 24.
PubMed 42034560
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Versus Direct Laryngoscopy for Double-lumen Tube Tracheal Intubation in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT06401486
- Acronym / sponsor ID
- DoLVi / DoLVi trial
- Keywords
- videolaryngoscopy, tracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 916 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 6 May 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.
Tracheal intubation (TI) is one of the fundamental and most recognized techniques in Anesthesiology, also essential in all units treating urgent pathology and critical patients. It involves advancing a tube through the vocal cords into the trachea to ventilate the patient. In thoracic surgery, it is often necessary to achieve lung isolation, ventilating only one lung while the operated lung remains collapsed and immobile. To achieve this, it is common to intubate the patient with a special tube: a double-lumen tube (DLT), larger than usual because it provides two ventilation channels, one for each lung.
Tracheal intubation with a DLT presents some peculiarities: its larger size and stiffness make manipulation and orientation in the oropharynx difficult. It has a curve at its distal end (the bronchial lumen) designed to slide into the left or right main bronchus as needed. The fact that the DLT passes between the vocal cords does not ensure its proper placement and function. Therefore, DLT intubation requires practice and experience, both to slide it between the vocal cords and to position it properly.
The classic technique for DLT intubation is "Direct Laryngoscopy" (DL). A traditional laryngoscope with a Macintosh blade is used to move the upper airway structures aside to allow direct visualization of the glottis. In recent years, to facilitate tracheal intubation, different videolaryngoscopes have appeared. A videolaryngoscope is a device similar to a traditional laryngoscope that allows, thanks to an image sensor located at its end, indirect visualization of the glottis on an integrated or external screen.
There is strong evidence for the benefit of using a VL over traditional DL in single-tube intubation in adult patients. However, although the use of VL for DLT intubation is becoming more common, there are few studies with small sample sizes comparing VL to DL for DLT intubation, so the evidence of its advantages or disadvantages is of low quality. It could improve glottic exposure and the percentage of success on the first attempt, although there is a possibility of increased tube malposition incidence and delayed intubation.
Therefore, Investigators propose a prospective, multicenter, randomized study comparing the traditional Macintosh blade laryngoscope (direct laryngoscopy) with the videolaryngoscope to facilitate orotracheal intubation with double-lumen tube in patients scheduled for thoracic surgery requiring lung isolation.
Detailed description
The purpose of this prospective multicenter randomized study is to compare successful intubation on the first attempt with the Macintosh laryngoscope vs the videolaryngoscope for double-lumen tube tracheal intubation in thoracic surgery. Investigators hypothesize that tracheal intubation using the videolaryngoscope will improve the frequency of successful intubation on the first attempt.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope group | Active comparator | Device: VideolaryngoscopeFor patients assigned to the videolaryngoscope Group, the operator will use a videolaryngoscope on the first laryngoscopy attempt. |
| Macintosh laryngoscope Group | Active comparator | Device: Macintosh laryngoscopeFor patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Patients admitted to any of the participating hospitals in the study who are undergoing thoracic surgery.
- Need for intubation with a double-lumen tube.
Key exclusion criteria (3 listed)
- Pregnant or lactating women.
- Individuals who do not have the capacity to understand their participation in the study.
- Need for tracheal intubation with a device other than videolaryngoscopy or direct laryngoscopy (fiberoptic bronchoscope, tracheostomy...).
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 |
|---|---|---|
| VideolaryngoscopeFor patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt. | Device | Videolaryngoscope group |
| Macintosh laryngoscopeFor patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt. | Device | Macintosh laryngoscope Group |
Primary outcome
Number of intubations with successful intubation on the first attempt
Time frame: Duration of procedure (minutes)
The primary outcome is defined as placement of a double lumen tube in the trachea with a single insertion of a videolaryngoscope blade into the mouth and either a single insertion of a double lumen tube into the mouth.
2 secondary outcomes
Successful intubation
Time frame: Duration of procedure (minutes)
Incidence of "easy intubation"
Time frame: Duration of procedure (minutes)
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 3 Feb 2026.
- Background: PubMed 34884226Karczewska K, Bialka S, Smereka J, Cyran M, Nowak-Starz G, Chmielewski J, Pruc M, Wieczorek P, Peacock FW, Ladny JR, Szarpak L. Efficacy and Safety of Video-Laryngoscopy versus Direct Laryngoscopy for Double-Lumen Endotracheal Intubation: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Nov 25;10(23):5524. doi: 10.3390/jcm10235524.
- Background: PubMed 32857788Kim YS, Song J, Lim BG, Lee IO, Won YJ. Different classes of videoscopes and direct laryngoscopes for double-lumen tube intubation in thoracic surgery: A systematic review and network meta-analysis. PLoS One. 2020 Aug 28;15(8):e0238060. doi: 10.1371/journal.pone.0238060. eCollection 2020.
- Background: PubMed 29405258Liu TT, Li L, Wan L, Zhang CH, Yao WL. Videolaryngoscopy vs. Macintosh laryngoscopy for double-lumen tube intubation in thoracic surgery: a systematic review and meta-analysis. Anaesthesia. 2018 Aug;73(8):997-1007. doi: 10.1111/anae.14226. Epub 2018 Feb 6.
- Derived from this study: PubMed 42034560Fernandez J, Francisco C, Seoane-Pillado T, Estany-Gestal A, Vazquez O, Aguirre P, Lopez RM, Lluch A, Reparaz JR, Vilar A, Arana V, Ceresuela R, Miron P, Gonzalez A, Romero JD, Otero MT, Gonzalez M, Carballo J, Minguez L, Blanco ML, Peiteado M, Casas P, Fernandez J, Martinez-Ragues G, Rodriguez A, Lopez D, Vargas MJ, Pereira D, Cortinas J, Garcia A, Blanco M, Sandoval M, Bolon A, Suarez P, Argente P, Lamas A, Ferreiroa E, Vilela M, Taboada M. Videolaryngoscopy versus direct laryngoscopy for double-lumen tube intubation: the DOuble-Lumen intubation with VIdeolaryngoscopy (DOLVI) multicentre randomised trial. Br J Anaesth. 2026 Jul;137(1):254-263. doi: 10.1016/j.bja.2026.02.048. Epub 2026 Apr 24.
- 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.
Manuel Taboada, Ph.D. principal investigator
Clinical University Hospital of Santiago de Compostela
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscope and Macintosh laryngoscope in people with Intubation Complication and Intubation; Difficult or Failed, run by Hospital Clinico Universitario de Santiago at 4 sites in Spain.
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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Number of intubations with successful intubation on the first attempt (time frame: Duration of procedure (minutes)). 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 NCT06401486, which also lists 4 linked publications.
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 3 Feb 2026.