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NCT Number: NCT06401486

DOuble-Lumen Intubation With VIdeolaryngoscopy

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complexo Hospitalario Universitario de A Coruña, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...).

Treatment and study plan

Videolaryngoscope

Device

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

Macintosh laryngoscope

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Successful intubation

    Time frame: Duration of procedure (minutes)

    Successful placement of a double lumen tube in the trachea

  2. Incidence of "easy intubation"

    Time frame: Duration of procedure (minutes)

    Easy intubation is defined as a patient with Cormack-Lehane I-II glottic view and intubation on the first attempt.

Other outcomes

  1. Number of laryngoscopy attempts

    Time frame: Duration of procedure (minutes)

    Number of laryngoscopy attempts

  2. Number of attempts to cannulate the trachea with an endotracheal tube

    Time frame: Duration of procedure (minutes)

    Number of attempts to cannulate the trachea with an endotracheal tube

  3. Duration of laryngoscopy and tracheal intubation

    Time frame: Duration of procedure (minutes)

    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.

  4. Reason for failure to intubate on the first attempt

    Time frame: Duration of procedure (minutes)

    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
  5. Operator-assessed difficulty of intubation

    Time frame: Duration of procedure (minutes)

    Operator-assessed difficulty of intubation

    • without difficulty
    • mild difficulty
    • moderate difficulty
    • severe difficulty
  6. Modified Cormack-Lehane grade of glottic view

    Time frame: Duration of procedure (minutes)

    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
  7. Need for additional airway equipment

    Time frame: Duration of procedure (minutes)

    Airway equipment: bougie, stylet, other videolaryngoscope, others.

  8. Need to change the device for intubation

    Time frame: Duration of procedure (minutes)

    Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...).

  9. Use of external laryngeal pressure

    Time frame: Duration of procedure (minutes)

    External laryngeal pressure

  10. Malposition of the double lumen endotracheal tube

    Time frame: Duration of procedure (minutes)

    Malposition of the double lumen endotracheal tube

  11. Incidence of Dysphonia, hoarseness, or sore throat in the first 24 hours.

    Time frame: 24 hours after intubation

    Incidence of Dysphonia, hoarseness, or sore throat in the first 24 hours.

Sponsors and collaborators

Lead sponsor

Hospital Clinico Universitario de Santiago

Other

Registry information

Official study title

Video Versus Direct Laryngoscopy for Double-lumen Tube Tracheal Intubation in Thoracic Surgery

Acronym: DoLVi

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 6, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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