NCT05902858

Effect of Standard Laryngoscopy Versus Video-laryngoscopy

Efferct of Standard Laryngoscopy Versus Video-laryngoscop on First-attempt Success in Difficult Airways Undergoing ProVu TM Video Stylet Guided Intubationa (PROVU)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this open-label, randomized, 3-parallel arm trial is to compare success of intubation rate at first try between three groups that will be intubated: 1. Conventional intubation with hyperangulated videolaryngoscope (control group), 2. Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope, 3. Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope.

Detailed description

Critical anesthetic incidents in the operating room are often related to airway management. Difficult airway management is defined as the clinical situation in which an anesthesiologist with conventional training has difficulty with upper airway face mask ventilation, difficulty with tracheal intubation, or both. Airway management has undergone a major transformation since the development of hyper-angle videolaryngoscopy (VL). Recently, the ProVuTM video stylet (Flexicare Medical Ltd, Mountain Ash, UK), which combines visualization technology with a tube guidance system, has been proposed as a new device for endotracheal intubation in participants with difficult airway management. The investigators hypothesized that the ProVuTM video stylet combined with videolaryngoscopy or standard laryngoscopy may improve the success rate of intubation on the first attempt compared with using a videolaryngoscope alone in patientes with predicted difficult intubation. In fact, using ProVuTM the position of the video stylet tip can be adjusted continuously during the tracheal intubation maneuver.

Conditions

• Difficult Intubation

Interventions

Type	Name	Description
DEVICE	Conventional intubation with hyperangulated videolaryngoscope	After the induction of general anesthesia, the patient will undergo conventional intubation with hyperangulated videolaryngoscope
DEVICE	Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope	After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope
DEVICE	Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope	After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope

Timeline

• Start date: 2023-01-18
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: Italy