Prevalence of Major Vessels Underlying the Potential Incision Site for Emergency Front of Neck Airway Access in Adult Surgical Patients With Impalpable Neck Anatomy

NCT06637319 | Completed

• 1 other identifier: 22-0099-E
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing general anesthesia require assistance with their breathing and with the delivery of oxygen to their lungs. To achieve this, an anesthesiologist inserts a type of plastic breathing tube into the airway via the mouth called an endotracheal tube or laryngeal mask airway. In rare circumstances, the anesthesiologist may not be able to adequately provide oxygen via these methods. In this life-threatening situation, an anesthesiologist may be forced to make an incision in the front of the neck to access the trachea (windpipe) so that emergency oxygen can be provided. This life-saving technique is known as emergency front-of-neck access (eFONA) and is used to prevent low oxygen levels which cause irreversible brain damage and/or death. This rarely performed procedure carries a risk of harm from bleeding, injury to the airway or inability to access the trachea to provide oxygen. Emergency front of neck access is more likely to be required in patients with abnormal airway anatomy, for example, in patients with obesity and large neck circumference, neck cancer, or a history of head and neck radiation therapy. Though the optimal technique for eFONA is not clear, prominent guidelines advise the use of an 8-10cm incision upwards from the top of the breastbone in order to identify airway structures which cannot be easily felt by the anesthesiologist from the front of the intact neck. This differs from patients who have airway structures which may be easily located at the front of the neck, whereby a smaller incision may be made or a needle inserted into the trachea (widepipe) to provide oxygen. The neck contains major blood vessels which lie close to the airway and these blood vessels may be injured during the 8-10cm incision, creating further difficulty accessing the airway to provide life-saving oxygen. This study aims to assess for the presence and size of major blood vessels which may be damaged by this incision by using non-invasive ultrasound which will be placed on the skin of your neck to assess for such blood vessels prior to you undergoing anesthesia. Our study aims to assess the normal anatomy in the adult population such as yourself to understand what to expect when managing patients who require this life-saving therapy.

Conditions

Airway Complication of Anesthesia

Keywords

font of neck access; blood vessels; ultrasound

Outcome Measures

Primary Outcomes (1)

• Prevalence of blood vessels

  The prevalence of blood vessels at front of neck on ultrasound where an emergency front of neck access vertical incision would take place. In total five regions looked at: sternal notch, thyroid gland, cricoid cartilage, cricothyroid membrane and thyroid cartilage

  During the procedure (30 minutes

Secondary Outcomes (3)

• Depth of blood vessels

  During the procedure (10 minutes)

• Diameter of blood vessels

  During the procedure (10 minutes)

• Distance from midline

  During procedure (10 minutes)

Study Arms (1)

Healthy Volunteers

Healthy volunteers \> 18 years of age

Device: Ultrasound

Interventions

Ultrasound DEVICE

Ultrasound scan of blood vessels where front of neck access vertical incision would take place in a cant intubate cant oxygenate scenario

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• Healthy volunteers
• Ability to understand the rationale of the study assessments and to provide signed consent
• Ability to safely and comfortably take part in the study protocol

You may not qualify if:

• Participant refusal
• Participant less than 18 years old or older than 80 years old
• Participants who do not speak English or cannot give informed written consent without assistance

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

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

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: December 1, 2024
• Primary Completion: February 15, 2025
• Study Completion: June 30, 2025
• Last Updated: January 28, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)