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Clinical Trials/NCT06401486
NCT06401486
Completed
Not Applicable

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

Hospital Clinico Universitario de Santiago8 sites in 1 country916 target enrollmentJuly 2, 2024

Overview

Phase
Not Applicable
Intervention
Macintosh laryngoscope
Conditions
Intubation Complication
Sponsor
Hospital Clinico Universitario de Santiago
Enrollment
916
Locations
8
Primary Endpoint
Number of intubations with successful intubation on the first attempt
Status
Completed
Last Updated
2 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2024
End Date
October 21, 2025
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manuel Taboada Muñiz

Proffesor

Hospital Clinico Universitario de Santiago

Eligibility Criteria

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...).

Arms & Interventions

Macintosh laryngoscope Group

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

Intervention: Macintosh laryngoscope

Videolaryngoscope group

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

Intervention: Videolaryngoscope

Outcomes

Primary Outcomes

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

  • Incidence of "easy intubation"(Duration of procedure (minutes))
  • Successful intubation(Duration of procedure (minutes))

Study Sites (8)

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