Effect of Standard Laryngoscopy Versus Video-laryngoscopy

Difficult Intubation Clinical Trial

— PROVU  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05902858
• Other study ID #: ASO.RianGen.22.03
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 114
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Device:
• Conventional intubation with hyperangulated videolaryngoscope
After the induction of general anesthesia, the patient will undergo conventional intubation with hyperangulated videolaryngoscope
• 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
• 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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo	Alessandria	Piedmont

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria	Flexicare Medical Ltd

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time of intubation	Time from insertion of the laryngoscope beyond the dental rhyme to cuffed tube	During the procedure
Secondary	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
Secondary	Number of intubation attempts	Times of reinsertion of the tube beyond the dental rhyme	During the procedure
Secondary	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
Secondary	Use of "jaw trust" or "BURP"	Need to perform adjuvant maneuvers (jaw trust or BURP), measured with yes/no	During the procedure
Secondary	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
Secondary	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
Secondary	Learning curve analysis of intubation rate success	Improvement of intubation rate success	Through study completion, an average of 1 year
Secondary	Learning curve analysis of time of procedure	Improvement of time of procedure	Through study completion, an average of 1 year