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Aspiration in Acute Respiratory Failure Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02363686
Recruitment Status : Active, not recruiting
First Posted : February 16, 2015
Last Update Posted : January 18, 2020
National Heart, Lung, and Blood Institute (NHLBI)
Boston University
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dysphagia Procedure: FEES Procedure: BSE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Aspiration in Acute Respiratory Failure Survivors
Study Start Date : February 2012
Actual Primary Completion Date : August 31, 2018
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
FEES & Bedside Swallow Evaluation (BSE)
Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).
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.
Other Name: Fiberoptic Endoscopic Evaluation of Swallowing

Procedure: 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.
Other Name: Bedside Swallowing Evaluation

Primary Outcome Measures :
  1. To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently diagnose aspiration in ARF survivors. [ Time Frame: from extubation Day 1 through hospital discharge, expected to be within 28 days ]
    Aspiration (PAS score of ≥6) on the FEES with any of the five feedings.

Secondary Outcome Measures :
  1. ICU and hospital length of stay, and length of stay after extubation [ Time Frame: Day 1 through Day 28 ]
    Collected as ICU and hospital free days at Day 28. ICU and hospital free days are defined as the number of days from day 1 to day 28 that a patient is alive and not in an ICU or hospital. Length of stay after extubation will be calculated similarly, using the date of extubation (as opposed to the date of admission) as the start time.

  2. Duration of mechanical ventilation [ Time Frame: Day 1 through Day 28 ]
    This will be quantified as the number of ventilator free days at Day 28 from the time of enrollment in this clinical trial. Ventilator free days is a standard measure of duration of mechanical ventilation defined as the number of days from day 1 to day 28 on which a patient breathed without assistance, if the period of unassisted breathing lasted at least 48 consecutive hours. A difference in ventilator free days reflects a difference in mortality, ventilator days among survivors, or both. This is a standard outcome measure that has been utilized in several large clinical trials

  3. Place of discharge [ Time Frame: Day 1 through Day 28 ]
    For those patients who are discharged from the hospital, we will record their location of discharge in a dichotomous manner: home or other facility (skilled nursing facility, rehabilitation center, or long term acute care hospital). We will also have recorded where the patient lived prior to hospital admission.

  4. Mortality [ Time Frame: Day 28 and Day 60 ]
    We will collect all cause mortality data on days 28 and 60.

  5. Placement of a surgical feeding tube [ Time Frame: Day 1 through Day 28 ]
    This will be defined as the placement of a feeding tube in the stomach or jejunum by a surgeon, gastroenterologist, or interventional radiologist.

  6. Days of no oral intake [ Time Frame: Day 28 and Day 60 ]
    Calculated at Day 28 and Day 60. This will be collected in similar fashion to ventilator-free days, designating a day when the patient's diet order was for nothing by mouth (NPO) a day without oral intake.

  7. Days with a temporary feeding tube [ Time Frame: Day 1 through Day 28 ]
    Defined as the placement of a temporary naso-gastric feeding tube (including large-bore as well as small bore (dobbhoff) tubes.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02363686

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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States
Sponsors and Collaborators
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Boston University
National Institute of Nursing Research (NINR)
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Principal Investigator: Marc Moss, MD University of Colorado, Denver
Report on the ASHA Speech-Language Pathology Health Care Survey American Speech-Language-Hearing Association. 2011 SLP health care survey summary report: Number and type ofresponses. Available from: 2011; 1-49.
Langmore SE, Pelletier C, Nelson. Results of FEES survey on safety of endoscopy for swallowing assessment. Presented at Fourth Annual Meeting of the Dysphagia Research Society, McLean, VA, October 28, 1995.
Guidelines and procedures for monitoring VAP. 2011. United States Centers for Disease Control and Prevention (CDC) and National Healthcare Safety Network (NHSN). 22 December 2011. 2011; 1-12.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver Identifier: NCT02363686    
Other Study ID Numbers: 12-0184
5K24HL089223 ( U.S. NIH Grant/Contract )
1R21NR015886-01 ( U.S. NIH Grant/Contract )
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases