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Difficult IntubationVCINCT06537531

Video Classification of Intubation in Spain (VCI)

An observational study of Difficult Intubation, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Use of VCI in Spain Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Difficult Intubation
What is being tested?
Compare VCI scale
How many people
1,500 participants
Where
2 sitesSpain
Study dates
26 Jul 2024to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients from any geographical area of the Iberian Peninsula who decide to undergo scheduled surgery at our hospital during a period of 6 months (2024-25).

Who may be able to join

  • Patients from any geographical area of the Iberian Peninsula who decide to undergo scheduled surgery at our hospital during a period of 6 months (2024-25).

Who cannot join

  • Age <18

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Miguel Angel Fernandez-Vaquero, MD, PhD contact

0034913531920 ext. 7633

mfvaquero@unav.es

Spain2 sites, 2 recruiting
  • Clinica Universidad de Navarra

    Madrid, Madrid, 28027

    Miguel Angel Fernandez Vaquero, MD, +34913531920 ext. 7633, mfvaquero@unav.es

    Recruiting
  • Miguel Angel Fernandez-Vaquero

    Madrid, Madrid, 28027

    Miguel Angel Fernandez-Vaquero, MD, PhD, 0034913531920 ext. 7633, mfvaquero@unav.es

    Recruiting

Other trials in Spain

About this study

Official title: Video Classification of Intubation in Spain

Use of VCI in Spain

Read the 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.

Being tested
Compare VCI scale
Keywords
Difficult intubation, Airway, Videolaryngoscopy, Score

What participants receive

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

  • Compare VCI scaleOther

    Compare VCI scale

Study groups in NCT06537531
Study groupRoleWhat they receive
PatientsPatients from any geographical area of the Iberian Peninsula who decide to undergo scheduled surgery at our hospital during a period of 6 months (2024-25).
Receives: Other: Compare VCI scale

What is being measured

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

  1. VCI scale from observer (1-4)

    VCI scale from observer(1-4)

    Measured: 2 minutes

  2. VCI scale from intubator (1-4)

    VCI scale from intubator (1-4)

    Measured: 2 minutes

Timeline

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

  1. First posted5 Aug 2024
  2. Study start26 Jul 2024
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06537531
Sponsor's protocol ID
2022.079
Acronym
VCI
Status last verified
Jan 2026
First submitted
26 Jul 2024
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fernandez-Vaquero MA, Charco-Mora P, Sastre-Rincon JA, Gomez-Rios MA, Cardenas-Gomez J, Martinez-Hurtado E, Aracil-Escoda N, Vallejo-Tarrat A, Thion-Soriano I, Peral-Sanchez D, Castaneda-Pascual M, Rodriguez Del Rio M, de Luis-Cabezon N, Gonzalez-Garcia J, Acosta-Martinez J, Gonzalez-Santos S, Onrubia-Fuertes X, Martinez-Gonzalez E, Roca de Togores-Lopez A, Gonzalez-Mendibil I, Banos-Maestro A, Mariscal-Flores M, Lluch-Oltra A, Emazabel-Yunta I, Rodriguez-Sanabria DM, Alvarez-Avello JM, Melendez Salinas DA, Lopez-Correa T, Sanchez-Merchante M, Bermudez-Lopez M, Martinez-Gallego E, Martinez-Segovia MC, Martin-Andres AB, Molero-Diez Y, Garcia-Aroca MA, Tapia-Salinas B, Puig-Bernabe J, Piano A, Hernandez-Fernandez G, Mingote-Llado A, Garcia-Fernandez J, Mata-Estevez J, Reviriego-Agudo L, Ruiz-Cordoba G, Moya-Moradas J, Marques-Asin FJ, Santacana MV; VCISpain Trial Investigators Group. VCISpain: protocol for a prospective multicenter observational study to validate a standardized classification tool for tracheal intubation using videolaryngoscopy. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844653. doi: 10.1016/j.bjane.2025.844653. Epub 2025 Jun 18.

    PubMed 40553732

Questions about this trial

What is this clinical trial studying?

An observational study of Difficult Intubation, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Miguel Angel Fernandez-Vaquero, MD, PhD (0034913531920 ext. 7633, mfvaquero@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VCI scale from observer (1-4) (time frame: 2 minutes). The study lists 2 primary outcomes in all. 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 NCT06537531, which also lists 1 linked publication.

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 6 Jan 2026.

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