Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Swallowing, Air
• Intervention / Treatment: Other: waiting period

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing treatment for airway stenosis who present to the University of Alabama at Birmingham Voice Center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Blake Simpson, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Aerophagy
• Other Study ID Numbers: IRB-300005704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No