Videolaryngoscopy vs Direct Laryngoscopy for Double Lumen Tube Lumen Tube Placement - A Multicentre Randomized-controlled Trial (VOLCANO Study)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorLuca Brazzi

About this trial

The general aim of the study is to observe whether the use of the Mc Grath™ videolaryngoscope instead of direct laryngoscopy can represent, as in the case of the single-lumen tube, an added value in the placement of the double-lumen tube for surgical procedures involving one-lung ventilation, making intubation on the first attempt more likely and quicker. Secondary objectives include evaluating the presence of an advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for the correct placement of the double-lumen tube, the need for additional maneuvers during the intubation procedure, and the presence of intra- and post-procedural complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

General anesthesia

One-lung ventilation via double-lumen tube

Disqualifiers

Patients who refuse to consent to participation in the study.

Patients scheduled for awake intubation due to pre-operative evaluation findings of predictors of difficult oxygenation that contraindicate intubation under general anesthesia.

Patients with anatomical anomalies leading to tracheal and/or laryngeal displacement/compression.

Patients with contraindications to double-lumen tube placement.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mc Grath Videolaryngoscope

    Device

    Use of Videolaryngoscope with Mc Grath versus direct laryngoscopy

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: VOLCANO - double lumen tube placement with direct laryngoscopyNo intervention 0 interventions
Group B: VOLCANO - double lumen tube placement with videolaryngoscopyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of partecipant with first pass intubation success

first pass intubation success of the Mc Grath™ videolaryngoscope over direct laryngoscopy for double-lumen tube intubation.

Time frame
up to 1 hour

Secondary outcomes

1

Intubation-related complications

Evaluation of the advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for intra- and post-procedural complications, need for additional maneuvers, and correct placement of the double-lumen tube.

Time frame
24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luca Brazzi

Lead sponsor

University of Turin, Italy

Sponsor institution

A.O.U. Città della Salute e della Scienza - Molinette Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: