Airway Coach Project: Prediction of Videolaryngoscopy Strategy With Clinical and Ultrasound Parameters (Unicentric)

NCT ID: NCT06925009

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-27
• Study Completion Date: 2026-06-01

Brief Summary

This unicentric observational study collects clinical characteristics, demographic data, and point-of-care airway ultrasound measurements in patients undergoing videolaryngoscopy. These variables are analysed using machine-learning techniques to examine their association with predefined videolaryngoscopy-related outcomes, including blade performance and adjunct requirement.

Detailed Description

Tracheal intubation is a routine procedure in anaesthesia and critical care; however, difficulties during videolaryngoscopy may still occur despite advances in airway devices. Conventional bedside airway assessments provide limited guidance for videolaryngoscopy-specific decisions, such as blade selection or anticipation of adjunct use.

This unicentric observational study collects clinical characteristics, demographic data, and point-of-care airway ultrasound measurements in patients undergoing videolaryngoscopy. These variables are analysed using machine-learning techniques to examine their association with predefined videolaryngoscopy-related outcomes, including blade performance and adjunct requirement.

The primary objective is to develop and internally evaluate a predictive model integrating multimodal data to support videolaryngoscopy strategy planning. The model is intended solely as a research and decision-support tool and does not replace clinician judgement. External validation in independent cohorts is planned.

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

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinica Universidad de Navarra

Madrid, 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 1

Identifier Type: -

Identifier Source: org_study_id