Effect of Standard Laryngoscopy Versus Video-laryngoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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

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Difficult Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open-label, randomized, 3-parallel arm, monocentric trial

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control Group

Conventional intubation with hyperangulated videolaryngoscope

Group Type ACTIVE_COMPARATOR

Conventional intubation with hyperangulated videolaryngoscope

Intervention Type DEVICE

After the induction of general anesthesia, the patient will undergo conventional intubation with hyperangulated videolaryngoscope

Provu TM video stylet + hyperangulated videolaryngoscope

Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope

Group Type EXPERIMENTAL

Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope

Intervention Type DEVICE

After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope

Provu TM video stylet + Macintosh laryngoscope

Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope

Group Type EXPERIMENTAL

Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope

Intervention Type DEVICE

After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope

Interventions

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Conventional intubation with hyperangulated videolaryngoscope

After the induction of general anesthesia, the patient will undergo conventional intubation with hyperangulated videolaryngoscope

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No