Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Treatment Group 1: 90 min waiting period Participants undergo their planned tracheobronchoscopy + 90 minute waiting period prior to modified functional endoscopic swallowing exam
  • Other: waiting period
    amount of time between clinical procedure and modified functional endoscopic exam of swallowing
Treatment Group 2: 66 min waiting period Participants undergo their planned tracheobronchoscopy + 66 minute waiting period prior to modified functional endoscopic swallowing exam
  • Other: waiting period
    amount of time between clinical procedure and modified functional endoscopic exam of swallowing
Treatment Group 3: 46 min waiting period Participants undergo their planned tracheobronchoscopy + 46 minute waiting period prior to modified functional endoscopic swallowing exam
  • Other: waiting period
    amount of time between clinical procedure and modified functional endoscopic exam of swallowing
Treatment Group 4: 28 min waiting period Participants undergo their planned tracheobronchoscopy + 28 minute waiting period prior to modified functional endoscopic swallowing exam
  • Other: waiting period
    amount of time between clinical procedure and modified functional endoscopic exam of swallowing
Treatment Group 5: 13 min waiting period Participants undergo their planned tracheobronchoscopy + 13 minute waiting period prior to modified functional endoscopic swallowing exam
  • Other: waiting period
    amount of time between clinical procedure and modified functional endoscopic exam of swallowing

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Blake Simpson, MD
205-801-7863
blakesimpson@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Blake Simpson, MD
(205) 801-7863
blakesimpson@uabmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.