Effect of Standard Laryngoscopy Versus Video-laryngoscopy

NCT05902858 | Unknown

• 1 other identifier: ASO.RianGen.22.03
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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. 1.Conventional intubation with hyperangulated videolaryngoscope (control group),
2. 2.Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope,
3. 3.Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope.

Conditions

Difficult Intubation

Keywords

PROVU; Videolaryngoscopy; Laryngoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Time of intubation

  During the procedure

• Time of laryngoscopy

  During the procedure

• Number of intubation attempts

  During the procedure

• Complications

  During the procedure

• Use of "jaw trust" or "BURP"

  During the procedure

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Conventional intubation with hyperangulated videolaryngoscope

Device: Conventional intubation with hyperangulated videolaryngoscope

Provu TM video stylet + hyperangulated videolaryngoscope

EXPERIMENTAL

Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope

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

Provu TM video stylet + Macintosh laryngoscope

EXPERIMENTAL

Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope

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

Interventions

Conventional intubation with hyperangulated videolaryngoscope DEVICE

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

Control Group

Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope 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 + hyperangulated videolaryngoscope

Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope DEVICE

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

Provu TM video stylet + Macintosh laryngoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ≤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.

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead
• Flexicare Medical Ltd: collaborator

Study Sites (1)

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Alessandria, Piedmont, 15121, Italy

Location

Related 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.

  PMID: 33817645 BACKGROUND

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Mirco Leo, Physician

  Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label, randomized, 3-parallel arm, monocentric trial

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: June 15, 2023
• Study Start: January 18, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)