Aspiration in Acute Respiratory Failure Survivors

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Procedure: FEES; Procedure: BSE

• Registration Number: NCT02363686
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-16
• Primary Completion: 2018-08-31
• Study Completion: 2020-11-30
• Results First Submitted: 2021-03-08
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-18
• Last Update Submitted: 2021-06-18
• Results First Posted: 2021-07-12
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FEES & Bedside Swallow Evaluation (BSE)	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 & Bedside Swallow Evaluation (BSE)	FEES	Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States