Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia

NCT04575870 | Completed

• 1 other identifier: IRB-300005704
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Swallowing, Air

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

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

Interventions

waiting period OTHER

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

Treatment Group 1: 90 min waiting period; Treatment Group 2: 66 min waiting period; Treatment Group 3: 46 min waiting period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Aerophagy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Blake Simpson, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: October 5, 2020
• Study Start: November 18, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)