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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Videolaryngoscope group | Active Comparator | For patients assigned to the videolaryngoscope Group, the operator will use a videolaryngoscope on the first laryngoscopy attempt. |
|
| Macintosh laryngoscope Group | Active Comparator | For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Videolaryngoscope | Device | For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Duration of procedure (minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Successful intubation | Successful placement of a double lumen tube in the trachea | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of laryngoscopy attempts | Number of laryngoscopy attempts | Duration of procedure (minutes) |
| Number of attempts to cannulate the trachea with an endotracheal tube | Number of attempts to cannulate the trachea with an endotracheal tube |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Taboada, Ph.D. | Clinical University Hospital of Santiago de Compostela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complexo Hospitalario Universitario de A Coruña | A Coruña | Spain | ||||
| Complexo Hospitalario Universitario de Santiago de Compostela |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34884226 | Background | 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. | |
| 32857788 |
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| Macintosh laryngoscope | Device | For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt. |
|
| Duration of procedure (minutes) |
| Duration of procedure (minutes) |
| Duration of laryngoscopy and tracheal intubation | The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of a double lumen tube in the trachea. | Duration of procedure (minutes) |
| Reason for failure to intubate on the first attempt | Reason for failure among those who did not meet the primary outcome (successful intubation on the first attempt):
| Duration of procedure (minutes) |
| Operator-assessed difficulty of intubation | Operator-assessed difficulty of intubation
| Duration of procedure (minutes) |
| Modified Cormack-Lehane grade of glottic view | Modified Cormack-Lehane grade of glottic view:
| Duration of procedure (minutes) |
| Need for additional airway equipment | Airway equipment: bougie, stylet, other videolaryngoscope, others. | Duration of procedure (minutes) |
| Need to change the device for intubation | Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...). | Duration of procedure (minutes) |
| Use of external laryngeal pressure | External laryngeal pressure | Duration of procedure (minutes) |
| Malposition of the double lumen endotracheal tube | Malposition of the double lumen endotracheal tube | Duration of procedure (minutes) |
| Incidence of Dysphonia, hoarseness, or sore throat in the first 24 hours. | Incidence of Dysphonia, hoarseness, or sore throat in the first 24 hours. | 24 hours after intubation |
| Santiago de Compostela |
| Spain |
| Hospital Universitario La Fe de Valencia | Valencia | Spain |
| Complexo Hospitalario Universitario Vigo | Vigo | Spain |
| Kim 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. |
| 29405258 | Background | Liu 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. |
| 42034560 | Derived | Fernandez 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 Apr 24:S0007-0912(26)00207-2. doi: 10.1016/j.bja.2026.02.048. Online ahead of print. |