Aspiration in Acute Respiratory Failure Survivors



Status:Active, not recruiting
Conditions:Hospital, Gastrointestinal, Pulmonary
Therapuetic Areas:Gastroenterology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:February 2012
End Date:August 2019

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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.

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.

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.
We found this trial at
3
sites
1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Marc Moss, MD
Phone: 720-848-4210
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-785-3490
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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