Clinical trial NCT06925009: Ultrasound Parameters for Difficult Videolaryngoscopy (Unicentric)
Official title: Ultrasound Parameters to Predict Difficult Videolaryngoscopy. Parámetros de Ultrasonido Para Videolaringoscopia Difícil (Estudio Unicéntrico)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Difficult Videolaryngoscopy
Keywords: Ultrasound;Difficult Videolaryngoscopy
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.

Brief summary: Ultrasound has become an essential tool for the daily work of any doctor, but in certain specialties such as Anaesthesiology, its use has greatly increased the safety offered to patients throughout the perioperative period, either to perform nerve blocks, for vascular access, intraoperative hemodynamic management or any other use that allows increasing quality of care.

Detailed description: The management of the upper airway and the diagnosis of pathological conditions are essential skills for any doctor especially for Anaesthesiologist, ER physician, or Intensive Care physician. Because an inadequate airway management continues to be an important contributor to patient mortality and morbidity, any tool that can improve it should be considered as an addition to conventional clinical evaluation.

Unfortunately, most of the clinical parameters that should allow us to assess a potential difficult airway, do not always lead us to an adequate prediction, that is why US(Ultrasound) is use as an emerging tool in many fields, is also gathering strength in this search for a definitive predictor parameter.

Ultrasound has many obvious advantages (safe,fast, repeatable, portable, widely available and gives dynamic images in real time).

Sonographic studies are operator-dependent and although the identification of basic structures could be acquired with only a few hours of training, but more complex studies require a learning curve of months or even years. The high frequency linear probe (5-14 MHz) is probably the most suitable for the airway because images are of superficial structures (within 0-5 cm below the skin surface).

The growing academic interest in the use of US to look for predictors of difficult airway is centred mainly on measurements at the level of pretracheal tissues. But the greatest limitation of these studies is the disparity of the fat distribution that exists between different ethnic groups and and sexes, and the lack of standardization method in patient´s intubation conditions.

So, this study propose to assess different ultrasound windows at the level of pretracheal tissues such as independent predictors of Difficult Vydeolaryngoscopy.

Eligibility criteria: Inclusion Criteria:

* Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.

Exclusion Criteria:

* Obesity class II defined as a BMI greater than 35.
* Pregnant.
* Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
* Abnormalities that condition anatomy alterations such as facial / cervical fractures.
* Maxillofacial abnormalities
* People who cannot give their consent

Primary outcomes:
measure: Distance from skin to Hyoid bone measured with lineal ultrasound probe
timeFrame: 5 minutes
measure: Distance from skin to epiglottis measured with lineal ultrasound probe
timeFrame: 5 minutes
measure: Tongue Thickness measured with convex probe
timeFrame: 5 minutes
measure: Distance from Jaw to Hyoid bone distance measured with convex probe
timeFrame: 5 minutes
Secondary outcomes:
measure: Modified Mallampati Score Class I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, major part of uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible.
timeFrame: 1minute
measure: Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended
timeFrame: 1minute
measure: Sternomental distance the distance from the suprasternal notch to the mentum and is measured with the head fully extended on the neck and the mouth closed
timeFrame: 1minute
measure: Interincisor distance DIstance in centimeters between fornt incisors
timeFrame: 1minute
measure: Upper Lip Bite Test upper lip bite criteria-class I = lower incisors can bite the upper lip above the vermilion line, class II = lower incisors can bite the upper lip below the vermilion line, and class III = lower incisors cannot bite the upper lip
timeFrame: 1minute
measure: neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured
timeFrame: 1minute
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
Study officials:
References: