Ultrasound Parameters to Predict Difficult Videolaryngoscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Difficult Videolaryngoscopy
• Intervention / Treatment: Diagnostic test: Ultrasound mesurements

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.

• Study Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28027
    • Recruiting
    • Clinica Universidad de Navarra
    • Contact: Miguel Angel Fernandez-Vaquero, MD, PhD; Phone Number: 7633 +34913531920; Email: mfvaquero@unav.es
    • Sub-Investigator: Eugenio Martinez-Hurtado, MD
    • Sub-Investigator: Nekari De Luis-Cabezon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient undergoing general anesthesia with videolaryngoscopy intubation; Patient undergoing general anesthesia with intubation We will explore clinical airway parameters and external ultrasound parameters of the airway.	Diagnostic test: Ultrasound mesurements; Compare various clinical test with ultrasound parameters to predict difficult videolaryngoscopy intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Distance from skin to Hyoid bone measured with lineal ultrasound probe	5 minutes
Distance from skin to epiglottis measured with lineal ultrasound probe	5 minutes
Tongue Thickness measured with convex probe	5 minutes
Distance from Jaw to Hyoid bone distance measured with convex probe	5 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	1minute
Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended	1minute
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	1minute
Interincisor distance DIstance in centimeters between fornt incisors	1minute
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	1minute
neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured	1minute

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: Hospital de Basurto; Hospital Universitario Infanta Leonor

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound;Difficult Videolaryngoscopy
• Other Study ID Numbers: MAFV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No