Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia

NCT ID: NCT04575870

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-18
• Study Completion Date: 2023-01-31

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.

Conditions

Swallowing, Air

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment Group 1: 90 min waiting period

Participants undergo their planned tracheobronchoscopy + 90 minute waiting period prior to modified functional endoscopic swallowing exam

waiting period

Intervention Type: OTHER

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

waiting period

Intervention Type: OTHER

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

waiting period

Intervention Type: OTHER

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

Interventions

waiting period

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Blake Simpson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Blake Simpson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300005704

Identifier Type: -

Identifier Source: org_study_id