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Difficult IntubationPROVUNCT05902858

Effect of Standard Laryngoscopy Versus Video-laryngoscopy

A study testing Conventional intubation with hyperangulated videolaryngoscope, Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope and Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope in people with Difficult Intubation, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Difficult Intubation
What is being tested?
Conventional intubation with hyperangulated videolaryngoscope, Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope and Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteItaly
Study dates
18 Jan 2023to Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • ≤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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

    Alessandria, Piedmont, 15121

Other trials in Italy

About this study

Official title: 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.
Read the 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.

Being tested
Conventional intubation with hyperangulated videolaryngoscope, Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope, Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope
Keywords
PROVU, Videolaryngoscopy, Laryngoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional intubation with hyperangulated videolaryngoscopeDevice

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

  • Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscopeDevice

    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 laryngoscopeDevice

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

Study groups in NCT05902858
Study groupRoleWhat they receive
Control GroupActive comparatorConventional intubation with hyperangulated videolaryngoscope
Receives: Device: Conventional intubation with hyperangulated videolaryngoscope
Provu TM video stylet + hyperangulated videolaryngoscopeExperimentalIntubation ProVu TM video stylet combined with hyperangulated videolaryngoscope
Receives: Device: Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope
Provu TM video stylet + Macintosh laryngoscopeExperimentalIntubation ProVu TM video stylet combined with standard Macintosh laryngoscope
Receives: Device: Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During the procedure

Secondary outcomes (9)

  1. Time of intubation

    Time from insertion of the laryngoscope beyond the dental rhyme to cuffed tube

    Measured: During the procedure

  2. Time of laryngoscopy

    Time from insertion of the laryngoscope beyond the dental rhyme to the insertion of the tube beyond the dental rhyme

    Measured: During the procedure

  3. Number of intubation attempts

    Times of reinsertion of the tube beyond the dental rhyme

    Measured: During the procedure

  4. Complications

    Evaluation of the type and rate of complications, including desaturation < 90%, esophageal intubation, tooth breakage and bleeding from the oropharyngeal mucosa

    Measured: During the procedure

  5. Use of "jaw trust" or "BURP"

    Need to perform adjuvant maneuvers (jaw trust or BURP), measured with yes/no

    Measured: During the procedure

  6. 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

    Measured: During the procedure

  7. 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

    Measured: During the procedure

  8. Learning curve analysis of intubation rate success

    Improvement of intubation rate success

    Measured: Through study completion, an average of 1 year

  9. Learning curve analysis of time of procedure

    Improvement of time of procedure

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start18 Jan 2023
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
open-label, randomized, 3-parallel arm, monocentric trial
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05902858
Sponsor's protocol ID
ASO.RianGen.22.03
Acronym
PROVU
Status last verified
Jan 2023
First submitted
23 Jan 2023
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33817645

  • Leo M, Zanza C, Mahajan A, Planinsic R, Piccolella F, Ruvolo D, Savarese B, Savioli G, Shiffer D, Voza A, Racca G, Panasyuk M, Leo R, Girombelli A, Saglietti F, Nuzzolo G, Mosca S, Racca F, Longhitano Y. Provu video stylet-assisted intubation under direct laryngoscopy and video laryngoscopy in high Arne score patients: a randomized clinical trial. BMC Anesthesiol. 2026 Mar 18;26(1):265. doi: 10.1186/s12871-026-03754-7.

    PubMed 41851852

Questions about this trial

What is this clinical trial studying?

A study testing Conventional intubation with hyperangulated videolaryngoscope, Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope and Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope in people with Difficult Intubation, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate on first intubation attemps (time frame: During the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05902858, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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