Video Classification of Intubation in Spain (VCI) (Pediatrics) (VCI)

Video Classification of Intubation in Spain (Pediatrics)

Use of VCI in Spain

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

The clinical importance of airway management has gained relevance over the last decade in most scientific societies with the objective of improving the standard of care.

The WHO has focused its guidelines on "Safe Surgery," aiming to encompass all methods that predict and recognize the risk of difficult airway management or aspiration, which must be applied by the surgical team. To this end, it has created and implemented a surgical safety checklist that can be useful in reducing the risk of unidentified difficulties.

The same suggestion has been included in the Helsinki Declaration on Patient Safety in Anesthesiology, endorsed by most European entities in cooperation with the European Society of Anesthesiology (ESA), the European Board of Anesthesiology (EBA-UEMS), the World Federation of Societies of Anesthesiology (WFA), and the European Patients' Federation (EPF). The protocol for difficult airway management and the implications of the Helsinki Declaration were published in 2013 in the Spanish Journal of Anesthesiology and Resuscitation.

Airway management today is perhaps the field that most concerns anesthesiologists, as decisions and actions must be taken quickly and effectively when facing a potential difficult airway (DA). Failure to do so would result in significant morbidity and mortality for patients.

The incidence of difficulty in orotracheal intubation (OTI) ranges between 1.5% and 13%. Most errors in airway management are due to ignorance and the low reliability of traditional protocols, algorithms, and combinations of detection tools to identify a potentially difficult airway.

This field is constantly evolving, and in the last 20 years, we have witnessed the emergence of a large number of devices: Supraglottic Devices (SGDs) or Extraglottic Devices (EGDs) in the past decade, and Optical Devices (videolaryngoscopes) in this last decade.

The existence of a large number of new devices in this field implies a deep understanding of these, both theoretically and practically, during scheduled surgery. Once this is achieved, practitioners should know how to use them appropriately in DA situations.

Since 1993, when the American Society of Anesthesiology (ASA) published its "Recommendations for Difficult Airway Management," many countries and scientific societies have created their protocols, guidelines, and algorithms that we must know and apply, always adapting them to our environment and the available devices.

In Spain, since the mid-1990s, DA training programs for specialist doctors have been launched, gradually expanding and covering all personnel involved in airway management. Today, training in this field has become part of the knowledge and skills acquisition in various specialties, notably Anesthesiology and Resuscitation.

The phrase "prevention is better than cure" is an intuitive, acceptable, and politically correct concept. This is applicable in our field since, although there are not many patient factors we can modify (anatomy is intrinsic), there are possible modifications in our actions that can determine the success or failure in airway management.

Currently, there is no universally accepted method for describing tracheal intubation via videolaryngoscopy. It is important that this information is communicated and documented accurately to plan airway management procedures for the patient, thereby improving care safety. The Intubation Classification Scale or Video Intubation Classification (VCI) score has been proposed to succinctly describe the key practical elements of tracheal intubation via videolaryngoscopy in the order they are performed. This classification consists of three sections: the first describes the type of blade used (Macintosh or hyperangulated), the second describes the POGO (Percentage of Glottic Opening) at the time of intubation, and finally, the ease/difficulty or impossibility of inserting the tube through the glottis.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

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

Study Contact

  • Name: Miguel Angel Fernandez-Vaquero, MD, PhD
  • Phone Number: 7633 0034913531920
  • Email: mfvaquero@unav.es

Study Locations

    • Madrid
      • Madrid, Madrid, Spain, 28027
        • Recruiting
        • Clínica Universidad de Navarra
        • Contact:
          • Miguel Angel Fernandez Vaquero, MD
          • Phone Number: 7633 +34913531920
          • Email: mfvaquero@unav.es
      • Madrid, Madrid, Spain, 28027
        • Recruiting
        • Miguel Angel Fernandez-Vaquero
        • Contact:
          • Miguel Angel Fernandez-Vaquero, MD, PhD
          • Phone Number: 7633 0034913531920
          • Email: mfvaquero@unav.es

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pediatric Patients from who decide to undergo scheduled surgery at our hospital during a period of 1 year (2025).

Description

Inclusion Criteria:

  • Pediatric Patients who decide to undergo scheduled surgery at our hospital during a period of 1 year (2025).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric Patients
Pediatric Patients from 20 Spanish Hospital scheduled surgery at our hospital during a period of 1 year (2025).
Compare VCI scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VCI scale from intubator
Time Frame: 2
VCI scale from intubator
2
VCI scale from observer
Time Frame: 2
VCI scale from observer
2

Collaborators and Investigators

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

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)

March 12, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2022.079 PEDIATRÍA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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