Clinical trial NCT02363686: Aspiration in Acute Respiratory Failure Survivors
Official title: Aspiration in Acute Respiratory Failure Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Boston University
name: National Institute of Nursing Research (NINR)
First posted: 2015-02-16
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Experiencing Aspiration
timeFrame: from extubation Day 1 through hospital discharge, expected to be within 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: University of Colorado, Denver
name: Marc Moss, MD
role: PRINCIPAL_INVESTIGATOR
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