Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT05902858
Status:
UNKNOWN
Last Update Posted:
2023-06-15
First Post:
2023-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Standard Laryngoscopy Versus Video-laryngoscopy
Sponsor:
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Organization:
Study Overview
Official Title:
Efferct of Standard Laryngoscopy Versus Video-laryngoscop on First-attempt Success in Difficult Airways Undergoing ProVu TM Video Stylet Guided Intubationa (PROVU)
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVU
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: