Effect of Standard Laryngoscopy Versus Video-laryngoscopy (PROVU)

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Status: Invitation-only

Conditions: Difficult Intubation

Treatments: Device: Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope; Device: Conventional intubation with hyperangulated videolaryngoscope; Device: Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT05902858

ASO.RianGen.22.03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 3 patient groups

Control Group

Active Comparator group

Description:

Conventional intubation with hyperangulated videolaryngoscope

Treatment:

Device: Conventional intubation with hyperangulated videolaryngoscope

Provu TM video stylet + hyperangulated videolaryngoscope

Experimental group

Description:

Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope

Treatment:

Device: Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope

Provu TM video stylet + Macintosh laryngoscope

Experimental group

Description:

Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope

Treatment:

Device: Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope