Effect of Standard Laryngoscopy Versus Video-laryngoscopy (PROVU)

June 5, 2023 updated by: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success rate on first intubation attemps
Time Frame: During the procedure
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time of intubation
Time Frame: During the procedure
Time from insertion of the laryngoscope beyond the dental rhyme to cuffed tube
During the procedure
Time of laryngoscopy
Time Frame: During the procedure
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
Time Frame: During the procedure
Times of reinsertion of the tube beyond the dental rhyme
During the procedure
Complications
Time Frame: During the procedure
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"
Time Frame: During the procedure
Need to perform adjuvant maneuvers (jaw trust or BURP), measured with yes/no
During the procedure
Need of another anesthesiologist intervention
Time Frame: During the procedure
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
Time Frame: During the procedure
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
Time Frame: Through study completion, an average of 1 year
Improvement of intubation rate success
Through study completion, an average of 1 year
Learning curve analysis of time of procedure
Time Frame: Through study completion, an average of 1 year
Improvement of time of procedure
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Flexicare Medical Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mirco Leo, Physician, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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