The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

  1. Admission to an ICU. 2. Mechanical ventilation with an endotracheal tube for greater than 48 hours.

Exclusion Criteria

  1. Contraindication to enteral nutrition administration. 2. Pre-existing history of dysphagia or aspiration. 3. Pre-existing or acute primary central or peripheral neuromuscular disorder. 4. Presence of a chronic tracheostomy (present prior to ICU admission). 5. Pre-existing head and neck cancer or surgery. 6. Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding. 7. Delirium for more than 72 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU). 8. Extubated for greater than 72 hours. 9. Inability to obtain informed consent from patient or an appropriate surrogate. 10. Age < 18 years.

Study Design

Study Type
Intervention Model
Single Group Assignment
Intervention Model Description
Multi-center prospective single cohort study
Primary Purpose
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Aspiration in Acute Respiratory Failure Survivors
All participants will receive a tracheal ultrasound within 72 hours prior to extubation, collection of demographic and hospital clinical information, administration of 3 screening tests (study defined algorithm test, 3-ounce water swallow test, TOR-BSST) addressing swallowing function within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) exam.
  • Diagnostic Test: 3-Screenings Protocol
    The 3-Screenings Protocol is a modified bedside swallow exam (BSE) consisting of a study developed five-item decision tree algorithm including voice quality assessment and a 2-ounce water consistency assessment, the Yale Swallow Test, with a scored 3-ounce Water Swallow Test (3-WST), and the Toronto Bedside Swallowing Screening Test (TOR-BSST).
    Other names:
    • Modified bedside swallow exam (BSE)
    • Three Screening Tests
  • Diagnostic Test: FEES
    A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.
    Other names:
    • Fiberoptic Endoscopic Evaluation of Swallowing
  • Diagnostic Test: Tracheal Ultrasound
    Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation

Recruiting Locations

Boston University
Boston, Massachusetts 02118
Gintas Krisciunas, MPH, MS

More Details

University of Colorado, Denver

Study Contact

Jeff McKeehan, RN,MSN

Detailed Description

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.


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.