Clinical trial NCT06881576: Video Classification of Intubation in Spain (VCI)
Official title: Video Classification of Intubation in Spain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Difficult Intubation
Keywords: Difficult intubation
Airway
Videolaryngoscopy
Score
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: VCI scale from intubator
timeFrame: minute 2
measure: VCI scale from observer
timeFrame: minute 2
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Miguel Angel Fernandez-Vaquero
Study officials:
References: