Ultrasound Parameters to Predict Difficult Videolaryngoscopy

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra (Other)
Overall Status
Recruiting
CT.gov ID
NCT05767099
Collaborator
Hospital Universitario Infanta Leonor (Other), Hospital de Basurto (Other)
210
1
16.1
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
210 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Ultrasound Parameters to Predict Difficult Videolaryngoscopy
Actual Study Start Date :
Jan 27, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Distance from skin to Hyoid bone measured with lineal ultrasound probe [5 minutes]

  2. Distance from skin to epiglottis measured with lineal ultrasound probe [5 minutes]

  3. Tongue Thickness measured with convex probe [5 minutes]

  4. Distance from Jaw to Hyoid bone distance measured with convex probe [5 minutes]

Secondary Outcome Measures

  1. 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]

  2. Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended [1minute]

  3. 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]

  4. Interincisor distance DIstance in centimeters between fornt incisors [1minute]

  5. 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]

  6. neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured [1minute]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinica Universidad de Navarra Madrid Spain 28027

Sponsors and Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra
  • Hospital Universitario Infanta Leonor
  • Hospital de Basurto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT05767099
Other Study ID Numbers:
  • MAFV
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra

Study Results

No Results Posted as of Mar 14, 2023