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Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04575870
Enrollment
30
Registered
2020-10-05
Start date
2020-11-18
Completion date
2023-01-31
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swallowing, Air

Brief 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.

Detailed 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.

Interventions

amount of time between clinical procedure and modified functional endoscopic exam of swallowing

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified functional endoscopic exam of swallowing (FEES)Up to 90 minutesA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026