DOuble-Lumen Intubation With VIdeolaryngoscopy

NCT06401486 | Completed

• 1 other identifier: DoLVi trial
• Study Type: interventional
• Target: 916
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Intubation Complication; Intubation; Difficult or Failed; Anesthesia; Videolaryngoscopy

Keywords

videolaryngoscopy; tracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Successful intubation

  Duration of procedure (minutes)

• Incidence of "easy intubation"

  Duration of procedure (minutes)

Other Outcomes (11)

• Number of laryngoscopy attempts

  Duration of procedure (minutes)

• Number of attempts to cannulate the trachea with an endotracheal tube

  Duration of procedure (minutes)

• Duration of laryngoscopy and tracheal intubation

  Duration of procedure (minutes)

Study Arms (2)

Videolaryngoscope group

ACTIVE COMPARATOR

For patients assigned to the videolaryngoscope Group, the operator will use a videolaryngoscope on the first laryngoscopy attempt.

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.

Device: Macintosh laryngoscope

Interventions

Videolaryngoscope DEVICE

For patients assigned to the videolaryngoscope Group, the operator will use a video laryngoscope on the first laryngoscopy attempt.

Videolaryngoscope group

Macintosh laryngoscope DEVICE

For patients assigned to the laryngoscope Group, the operator will use a Macintosh laryngoscope on the first laryngoscopy attempt.

Macintosh laryngoscope Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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...).

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (4)

Complexo Hospitalario Universitario de A Coruña

A Coruña, Spain

Location

Complexo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

Hospital Universitario La Fe de Valencia

Valencia, Spain

Location

Complexo Hospitalario Universitario Vigo

Vigo, Spain

Location

Related Publications (3)

• 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.

  PMID: 34884226 BACKGROUND

• 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.

  PMID: 32857788 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.

  PMID: 29405258 BACKGROUND

Study Officials

• Manuel Taboada, Ph.D.

  Clinical University Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: July 2, 2024
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)