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.
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.
Spain2 sites, 2 recruiting
- 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
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.
- Conditions
- Difficult Intubation
- 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 group | Role | What they receive |
|---|---|---|
| Patients | 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). Receives: Other: Compare VCI scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
VCI scale from observer (1-4)
VCI scale from observer(1-4)
Measured: 2 minutes
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.
- First posted5 Aug 2024
- Study start26 Jul 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Classification of Intubation in Spain
- ClinicalTrials.gov ID
- NCT06537531
- Acronym / sponsor ID
- VCI / 2022.079
- Conditions
- Difficult Intubation
- Keywords
- Difficult intubation, Airway, Videolaryngoscopy, Score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of VCI in Spain
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Compare VCI scalePatients 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 qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Age <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compare VCI scaleCompare VCI scale | Other | Patients |
Primary outcome
VCI scale from observer (1-4)
Time frame: 2 minutes
VCI scale from observer(1-4)
VCI scale from intubator (1-4)
Time frame: 2 minutes
VCI scale from intubator (1-4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 40553732Fernandez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.