Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia

Swallowing, Air Clinical Trial

Official title:

Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia (LTA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04575870
• Other study ID #: IRB-300005704
• Status: Completed
• Start date: November 18, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients undergo laryngotracheal anesthesia (LTA) for a variety of in-office laryngology procedures. Prior to resolution of laryngeal sensory anesthesia, oral intake may predispose patients to aspiration. The purpose of this study is to objectively characterize a time period for return of aspiration-free swallow after LTA.

Description:

Swallowing is a complex process involving coordination of multiple muscle groups. Sensation in the throat is very important for swallowing safely. Laryngotracheal anesthetic (LTA, or topical application of lidocaine anesthetic to larynx and trachea) is needed for a variety of in-office laryngology procedures, including examination of the air passage, or tracheobronchoscopy. This causes a temporary decrease in sensation that can affect swallow function and result in aspiration (passage of swallowed material into lungs instead of into esophagus and stomach). It is not known how long this effect lasts. It would be helpful to know this for counseling patients on when they can resume swallowing after a procedure. In general, most patients are advised to avoid eating/drinking for 90 minutes after their procedure to allow for sensation to return. To date, there has been no study characterizing the time required for return of aspiration-free swallow after LTA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Ability of patients to speak and understand English

• Ability for patients to consent for themselves

• Undergoing tracheobronchoscopy procedure for the treatment of airway stenosis

• Eating Assessment Tool (EAT-10) score = 3

Exclusion Criteria:

• Age less than 18 years

• Patients unable or unwilling to provide informed consent

• Women who are pregnant

• History of abnormal swallowing evaluation, either videofluroscopic study of swallow or functional endoscopic evaluation of swallowing (FEES)

• History of medical condition affecting swallowing, such as

• Neurodegenerative disorders: stroke, traumatic brain injury, dementia, motor neuron disease, myasthenia gravis, cerebral palsy, Gullain-Barre syndrome, poliomyelitis, myopathy, Parksonism, Huntingon's disease, progressive supranuclear palsy, Wilson's disease, vocal fold paralysis

• Connective tissue disorders: polymyositis, dermatomyositis, progressive systemic sclerosis, Sjogren's disease, scleroderma

• History of gastroesophageal tumor

• History of gastroesophageal surgery

• History of recent open central neck surgery (i.e., thyroidectomy, anterior cervical discectomy or fusion)

• History of head and neck cancer

• History of head and neck radiation therapy or chemotherapy

Related Conditions & MeSH terms

• Swallowing, Air

Intervention

Other:
• waiting period
amount of time between clinical procedure and modified functional endoscopic exam of swallowing

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified functional endoscopic exam of swallowing (FEES)	A modified functional endoscopic exam of swallowing (FEES) is an examination where a small amount of water will be ingested. Each subject will perform about three water swallows. Water will be dyed with green food coloring to facilitate visualization, as is standard with the FEES procedure. If the water passes normally to the esophagus, this will be considered a pass; if the water is aspirated, this will be considered a fail.	Up to 90 minutes