Ultrasound Parameters to Predict Difficult Airway

NCT04168840 | Completed

• 1 other identifier: UPDA
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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. 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, the investigator propose to assess different ultrasound windows at the level of pretracheal tissues such as independent predictors of Difficult Airway.

Conditions

Difficult Intubation

Keywords

ultrasound; difficult airway; difficult intubation

Outcome Measures

Primary Outcomes (4)

• Anterior neck soft tissue thickness measured by ultrasound at hyoid bone

  Distance from skin to the midline of hyoid bone measure with lineal ultrasound probe

  5 minutes

• Anterior neck soft tissue thickness measured by ultrasound at thyrohyoid membrane

  Distance from skin to midline of epiglottis measure with lineal ultrasound probe

  5 minutes

• Anterior neck soft tissue thickness measured by ultrasound at anterior commissure of vocal cords

  Distance from skin to anterior commisure of vocal cords measure with lineal ultrasound probe

  5 minutes

• Anterior neck soft tissue thickness measured by ultrasound at thyrohyoid membrane. Preepiglottic Area.

  Calculated with distance from skin to midline of epiglottis and 1 centimeterto left and right side.

  5 minutes

Secondary Outcomes (6)

• Modified Mallampati Score

  1 minute

• Thyromental distance

  1 minute

• Sternomental distance

  1 minute

• Interincisor distance

  1 minute

• Upper Lip Bite Test

  1 minute

Study Arms (1)

Patient undergoing general anesthesia with intubation

Patient undergoing general anesthesia with intubation We will explore clinical airway parameters and external ultrasound parameters of the airway

Diagnostic Test: Compare clinical test with ultrasound parameters

Interventions

Compare clinical test with ultrasound parameters DIAGNOSTIC_TEST

Compare various clinical test with four ultrasound parameters to predict difficult intubation.

Patient undergoing general anesthesia with intubation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing scheduled surgery requiring orotracheal intubation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clinica Universidad de Navarra

Madrid, 28027, Spain

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 19, 2019
• Study Start: May 1, 2019
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: March 16, 2021

Record last verified: 2020-01

Locations

ES (1)