Effect of Standard Laryngoscopy Versus Video-laryngoscopy

Last updated: June 5, 2023
Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope

Conventional intubation with hyperangulated videolaryngoscope

Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope

Clinical Study ID

NCT05902858
ASO.RianGen.22.03
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients undergoing elective surgery requiring oral tracheal intubation;
  • ≥18 years of age;
  • simplified Arné score ≥11;
  • Written informed consent will be obtained from every participant.

Exclusion

Exclusion Criteria:

  • ≤18 years of age
  • interincisor distance at maximal mouth opening ≤2 cm;
  • planned awake fiberoptic intubation because patients are patients considered to behigh-risk for difficult intubation or difficult mask ventilation (e.g. with necktumours, complete cervical arthrodesis; neck circumference >50 cm);
  • patients at risk of gastric aspiration
  • planned nasal intubation.

Study Design

Total Participants: 114
Treatment Group(s): 3
Primary Treatment: Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope
Phase:
Study Start date:
January 18, 2023
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

    Alessandria, Piedmont 15121
    Italy

    Site Not Available

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