DOuble-Lumen Intubation With VIdeolaryngoscopy (DoLVi)

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.

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Intubation Complication; Intubation; Difficult or Failed; Videolaryngoscopy
• Intervention / Treatment: Device: Videolaryngoscope; Device: Macintosh laryngoscope

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 Type: Interventional
• Enrollment (Actual): 916
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain
    • Complexo Hospitalario Universitario de A Coruña
  • Santiago de Compostela, Spain
    • Complexo Hospitalario Universitario de Santiago de Compostela
  • Valencia, Spain
    • Hospital Universitario La Fe de Valencia
  • Vigo, Spain
    • Complexo Hospitalario Universitario Vigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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...).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Videolaryngoscope group; For patients assigned to the videolaryngoscope Group, the operator will use a videolaryngoscope on the first laryngoscopy attempt.	Device: Videolaryngoscope; For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.
Active Comparator: Macintosh laryngoscope Group; For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.	Device: Macintosh laryngoscope; For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	Duration of procedure (minutes)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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): Inadequate view of the larynx; Inability to intubate the trachea with an endotracheal tube; Inability to cannulate the trachea with a bougie; Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding); Technical failure of the laryngoscope (e.g., battery, light source, camera, screen); Other	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)
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	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)
Operator-assessed difficulty of intubation	Operator-assessed difficulty of intubation; without difficulty; mild difficulty; moderate difficulty; severe difficulty	Duration of procedure (minutes)
Modified Cormack-Lehane grade of glottic view	Modified Cormack-Lehane grade of glottic view: I: full view of the glottis; IIa: partial view of the glottis; IIb: arytenoid or posterior part of the vocal cords just visible; III: only epiglottis visible; IV: neither glottis nor epiglottis visible 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)
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

Collaborators and Investigators

• Sponsor: Hospital Clinico Universitario de Santiago
• Investigators: Principal Investigator: Manuel Taboada, Ph.D., Clinical University Hospital of Santiago de Compostela

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Actual): October 21, 2025
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: tracheal intubation; videolaryngoscopy
• Other Study ID Numbers: DoLVi trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No