- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06881576
Video Classification of Intubation in Spain (VCI) (Pediatrics) (VCI)
Video Classification of Intubation in Spain (Pediatrics)
Study Overview
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
Enrollment (Estimated)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pediatric Patients who decide to undergo scheduled surgery at our hospital during a period of 1 year (2025).
Study Plan
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022.079 PEDIATRÍA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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