Effect of Standard Laryngoscopy Versus Video-laryngoscopy (PROVU)

Efferct of Standard Laryngoscopy Versus Video-laryngoscop on First-attempt Success in Difficult Airways Undergoing ProVu TM Video Stylet Guided Intubationa (PROVU)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Difficult Intubation
• Intervention / Treatment: Device: Conventional intubation with hyperangulated videolaryngoscope; Device: Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope; Device: Intubation with 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.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Conventional intubation with hyperangulated videolaryngoscope	Device: Conventional intubation with hyperangulated videolaryngoscope; After the induction of general anesthesia, the patient will undergo conventional intubation with hyperangulated videolaryngoscope
Experimental: Provu TM video stylet + hyperangulated videolaryngoscope; Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope	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
Experimental: Provu TM video stylet + Macintosh laryngoscope; Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate on first intubation attemps	The first-attempt intubation success is defined as tracheal tube placement with a single maneuver after insertion of the tube in the mouth. Reinsertion of the tube in the mouth counts as an additional attempt.	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of intubation	Time from insertion of the laryngoscope beyond the dental rhyme to cuffed tube	During the procedure
Time of laryngoscopy	Time from insertion of the laryngoscope beyond the dental rhyme to the insertion of the tube beyond the dental rhyme	During the procedure
Number of intubation attempts	Times of reinsertion of the tube beyond the dental rhyme	During the procedure
Complications	Evaluation of the type and rate of complications, including desaturation < 90%, esophageal intubation, tooth breakage and bleeding from the oropharyngeal mucosa	During the procedure
Use of "jaw trust" or "BURP"	Need to perform adjuvant maneuvers (jaw trust or BURP), measured with yes/no	During the procedure
Need of another anesthesiologist intervention	Required intervention of another anesthesiologist, measured with yes/no, after 3 failed intubation attempt or after request of the first anesthesiologist	During the procedure
Needs to change the path of the intubation strategy	Needs to change intubation strategy, measured with yes/no, includes use of fiberoptic intubation, change of videolaryngoscope or postpone intervention	During the procedure
Learning curve analysis of intubation rate success	Improvement of intubation rate success	Through study completion, an average of 1 year
Learning curve analysis of time of procedure	Improvement of time of procedure	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Collaborators: Flexicare Medical Ltd
• Investigators: Principal Investigator: Mirco Leo, Physician, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): June 1, 2023
• Study Completion (Estimated): June 1, 2023

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Videolaryngoscopy; Laryngoscopy; PROVU
• Other Study ID Numbers: ASO.RianGen.22.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No