Aspiration in Acute Respiratory Failure Survivors 2
Purpose
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.
Conditions
- Dysphagia
- Aspiration
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Admission to an ICU. 2. Mechanical ventilation with an endotracheal tube for greater than 48 hours.
Exclusion Criteria
- Likely persistent contraindications to enteral/oral 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 96 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU). 8. Extubated for greater than 96 hours. 9. Inability to obtain informed consent from patient or an appropriate surrogate. 10. Age < 18 years.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Multi-center prospective single cohort study
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other 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. |
|
Recruiting Locations
Boston, Massachusetts 02118
More Details
- Status
- Recruiting
- Sponsor
- University of Colorado, Denver
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.