Ultrasound Parameters to Predict Difficult Videolaryngoscopy

NCT ID: NCT05767099

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-27
• Study Completion Date: 2024-06-01

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.

Conditions

Difficult Videolaryngoscopy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ultrasound mesurements

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Ultrasound mesurements

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Infanta Leonor

OTHER

Sponsor Role: collaborator

Hospital de Basurto

OTHER

Sponsor Role: collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinica Universidad de Navarra

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Miguel Angel Fernandez-Vaquero, MD, PhD

Role: primary

mfvaquero@unav.es

+34913531920 ext. 7633

Other Identifiers

MAFV

Identifier Type: -

Identifier Source: org_study_id