Clinical trial NCT05902858: Effect of Standard Laryngoscopy Versus Video-laryngoscopy
Official title: Efferct of Standard Laryngoscopy Versus Video-laryngoscop on First-attempt Success in Difficult Airways Undergoing ProVu TM Video Stylet Guided Intubationa (PROVU)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Difficult Intubation
Keywords: PROVU
Videolaryngoscopy
Laryngoscopy
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
Collaborators: name: Flexicare Medical Ltd
First posted: 2023-06-15
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label, randomized, 3-parallel arm, monocentric trial
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Success rate on first intubation attemps
timeFrame: During the procedure
Secondary outcomes:
measure: Time of intubation
timeFrame: During the procedure
measure: Time of laryngoscopy
timeFrame: During the procedure
measure: Number of intubation attempts
timeFrame: During the procedure
measure: Complications
timeFrame: During the procedure
measure: Use of "jaw trust" or "BURP"
timeFrame: During the procedure
measure: Need of another anesthesiologist intervention
timeFrame: During the procedure
measure: Needs to change the path of the intubation strategy
timeFrame: During the procedure
measure: Learning curve analysis of intubation rate success
timeFrame: Through study completion, an average of 1 year
measure: Learning curve analysis of time of procedure
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
state: Piedmont
Study officials:
affiliation: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
name: Mirco Leo, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harrison SL, Ahmad I, Elwen F, Curtis A, Dua G, Surda P, Johnstone C. Awake tracheal intubation with the ProVu video stylet: a case series. Anaesth Rep. 2021 Mar 29;9(1):e12102. doi: 10.1002/anr3.12102. eCollection 2021 Jan-Jun.