Aspiration in Acute Respiratory Failure Survivors

Dysphagia Clinical Trial

Official title:

Aspiration in Acute Respiratory Failure Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363686
• Other study ID #: 12-0184
• Secondary ID: 5K24HL0892231R21
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: November 30, 2020
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysphagia
• Respiratory Insufficiency

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Boston University Medical Center	Boston	Massachusetts
United States	Yale University	New Haven	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Boston University, National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	from extubation Day 1 through hospital discharge, expected to be within 28 days