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Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia

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ClinicalTrials.gov Identifier: NCT04575870
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Blake Simpson, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment
Swallowing, Air 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia (LTA)
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2025

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

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




Primary Outcome Measures :
  1. Modified functional endoscopic exam of swallowing (FEES) [ Time Frame: Up to 90 minutes ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575870


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

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Blake Simpson, MD    205-801-7863    blakesimpson@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Blake Simpson, MD University of Alabama at Birmingham
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Responsible Party: Blake Simpson, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04575870    
Other Study ID Numbers: IRB-300005704
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aerophagy
Signs and Symptoms, Digestive