Clinical trial NCT04575870: Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia
Official title: Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia (LTA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Swallowing, Air
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing treatment for airway stenosis who present to the University of Alabama at Birmingham Voice Center.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified functional endoscopic exam of swallowing (FEES)
timeFrame: Up to 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Blake Simpson, MD
role: PRINCIPAL_INVESTIGATOR
References: