Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637319
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief 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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None