Clinical trial NCT05108896: Aspiration in Acute Respiratory Failure Survivors 2
Official title: Aspiration in Acute Respiratory Failure Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Aspiration
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-11-05
Enrollment: 855
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-center prospective single cohort study
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:

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.

Primary outcomes:
measure: Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies
timeFrame: from extubation day 1 through hospital discharge, expected to be within 28 days
Secondary outcomes:
measure: Percentage of participants experiencing non-silent aspiration
timeFrame: from extubation day 1 through hospital discharge, expected to be within 28 days
measure: Percentage of participants experiencing silent aspiration
timeFrame: from extubation day 1 through hospital discharge, expected to be within 28 days
measure: Percentage of participants experiencing post-extubation clinical laryngeal edema
timeFrame: Within 24 hours after extubation
measure: Duration of mechanical ventilation
timeFrame: from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
measure: Duration required for liberation from mechanical ventilation
timeFrame: from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Univerity
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: University of Colorado, Denver
name: Marc Moss, MD
role: PRINCIPAL_INVESTIGATOR
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