Clinical trial NCT06637319: Prevalence of Major Vessels Underlying the Potential Incision Site for Emergency Front of Neck Airway Access in Adult Surgical Patients With Impalpable Neck Anatomy
Official title: Prevalence of Major Vessels Underlying the Potential Incision Site for Emergency Front of Neck Airway Access in Adult Surgical Patients With Impalpable Neck Anatomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Airway Complication of Anesthesia
Keywords: font of neck access
blood vessels
ultrasound
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of blood vessels
timeFrame: During the procedure (10 minutes)
Secondary outcomes:
measure: Accuracy of marked line
timeFrame: During the procedure (10 minutes)
measure: Depth of blood vessels
timeFrame: During the procedure (10 minutes)
measure: Diameter of blood vessels
timeFrame: During the procedure (10 minutes)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References: