Dysphagia
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
PROCEDUREFEES
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.
PROCEDUREBSE
Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Boston University
National Institute of Nursing Research (NINR)
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects will be eligible to participate in the study if they meet all of the following criteria: 1. Admission to a University of Colorado Hospital ICU 2. Mechanical ventilation support through an endotracheal tube for greater than 24 hours
Exclusion criteria
* Subjects will be ineligible to participate in the study if they meet any of the following criteria 1. Age less than 18 years 2. Contraindication to enteral nutrition administration 3. Diagnosis of an acute or pre-existing central nervous system disorder (excluding a seizure disorder) 4. Pre-existing dysphagia 5. Previous surgery of the head, neck, or esophagus 6. Previous cancer of the head or neck 7. The presence of a tracheostomy 8. The presence of nasal or pharyngeal trauma or bleeding 9. Clinical team believes one of the protocols would be harmful to an individual patient 10. Expected survival less than 3 months 11. Pregnancy 12. Imprisoned at the time of admission, anytime during the hospitalization, or anytime during the followup period 13. Inability to give informed consent and proxy unavailable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Aspiration | from extubation Day 1 through hospital discharge, expected to be within 28 days | Aim: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently diagnose aspiration in ARF survivors. Aspiration (PAS score of ≥6) on the FEES with any of the five feedings. This outcome measure will report the percentage of participants experiencing silent and non-silent aspiration, as visualized on the FEES. The FEES is a flexible fiberoptic camera that allows the investigators to visualize the patient swallowing each of the 5 different consistencies of food. |
Countries
United States
Participant flow
Recruitment details
Overall, 213 patients were included in the final analysis
Participants by arm
| Arm | Count |
|---|---|
| FEES & Bedside Swallow Evaluation (BSE) Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).
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.
BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test. | 213 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | incomplete FEES examinations | 13 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | FEES & Bedside Swallow Evaluation (BSE) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 212 Participants |
| Age, Continuous | 57 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 54 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 42 Participants |
| Race (NIH/OMB) White | 117 Participants |
| Region of Enrollment United States | 213 participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 248 |
| other Total, other adverse events | 3 / 248 |
| serious Total, serious adverse events | 0 / 248 |
Outcome results
Primary
Percentage of Participants Experiencing Aspiration
Aim: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently diagnose aspiration in ARF survivors. Aspiration (PAS score of ≥6) on the FEES with any of the five feedings. This outcome measure will report the percentage of participants experiencing silent and non-silent aspiration, as visualized on the FEES. The FEES is a flexible fiberoptic camera that allows the investigators to visualize the patient swallowing each of the 5 different consistencies of food.
Time frame: from extubation Day 1 through hospital discharge, expected to be within 28 days
Population: Overall, 213 patients were included in the final analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FEES & Bedside Swallow Evaluation (BSE) | Percentage of Participants Experiencing Aspiration | Overall aspiration | 70 percentage of participants |
| FEES & Bedside Swallow Evaluation (BSE) | Percentage of Participants Experiencing Aspiration | Non-silent aspiration | 52 percentage of participants |