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

NCT06466759 | Not Yet Recruiting

• 1 other identifier: 915.982
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

One Lung Ventilation; Intubation Complication

Keywords

videolaryngoscope; double-lumen tube; one-lung ventilation

Outcome Measures

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.

  up to 1 hour

Secondary Outcomes (1)

• Intubation-related complications

  24 hours

Study Arms (2)

VOLCANO - double lumen tube placement with direct laryngoscopy

NO INTERVENTION

Patients will receive double lumen tube placement with direct laryngoscopy

VOLCANO - double lumen tube placement with videolaryngoscopy

ACTIVE COMPARATOR

Patients will receive double lumen tube placement with videolaryngoscopy

Device: Mc Grath Videolaryngoscope

Interventions

Mc Grath Videolaryngoscope DEVICE

Use of Videolaryngoscope with Mc Grath versus direct laryngoscopy

VOLCANO - double lumen tube placement with videolaryngoscopy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• General anesthesia
• One-lung ventilation via double-lumen tube

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luca Brazzi: lead
• A.O.U. Città della Salute e della Scienza - Molinette Hospital: collaborator

Central Study Contacts

Gerardo Cortese, MD

CONTACT

+39 0116335505; gcortese@cittadellasalute.to.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor, Clinical Director

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 20, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-06