Dysphagia, Aspiration
Conditions
Brief summary
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.
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.
Interventions
DIAGNOSTIC_TEST3-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).
DIAGNOSTIC_TESTFEES
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.
DIAGNOSTIC_TESTTracheal Ultrasound
Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation
Sponsors
National Institute of Nursing Research (NINR)
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Multi-center prospective single cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Admission to an ICU. 2. Mechanical ventilation with an endotracheal tube for greater than 48 hours.
Exclusion criteria
1. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies | from extubation day 1 through hospital discharge, expected to be within 28 days | Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants experiencing non-silent aspiration | from extubation day 1 through hospital discharge, expected to be within 28 days | We will stratify patients who aspirate into non-silent (PA = 6- 7) and silent (PAS=8) aspiration, and also determine maximum PAS scores across bolus and consistency types. Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies. We will also determine the maximum PAS scores across bolus and consistency types. |
| Percentage of participants experiencing silent aspiration | from extubation day 1 through hospital discharge, expected to be within 28 days | We will stratify patients who aspirate into non-silent (PA = 6- 7) and silent (PAS=8) aspiration, and also determine maximum PAS scores across bolus and consistency types. Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies. We will also determine the maximum PAS scores across bolus and consistency types. |
| Percentage of participants experiencing post-extubation clinical laryngeal edema | Within 24 hours after extubation | We will define laryngeal edema as upper-airway obstruction within 24 hours after extubation. Minor laryngeal edema will be defined as stridor associated with a respiratory distress defined as a prolonged inspiratory phase and the presence of edema on FEES examination. Major laryngeal edema will defined as severe respiratory distress needing tracheal reintubation secondary to upper-airway obstruction that was visualized during the FEES examination |
| Duration of mechanical ventilation | from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average | We will also collect the overall length of mechanical ventilation in days |
| Duration required for liberation from mechanical ventilation | from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average | We will also collect the overall length of the liberation process from mechanical ventilation in days |
Countries
United States
Contacts
Primary ContactJeff McKeehan, RN,MSN
Outcome results
None listed