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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02363686|
Recruitment Status : Recruiting
First Posted : February 16, 2015
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia||Procedure: FEES Procedure: BSE||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aspiration in Acute Respiratory Failure Survivors|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
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).
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
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
- 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.
- 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.
- 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
- 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.
- Mortality [ Time Frame: Day 28 and Day 60 ]We will collect all cause mortality data on days 28 and 60.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02363686
|Contact: Carrie Higgins, RN BSNfirstname.lastname@example.org|
|Contact: Jeff McKeehan, RN BSNemail@example.com|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Carrie Higgins, BSN 720-848-4210 firstname.lastname@example.org|
|Contact: Jeff McKeehan, BSN 303-724-6080 email@example.com|
|Principal Investigator: Marc Moss, MD|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06519|
|Contact: Jonathan M Siner, M.D. 203-785-3490 firstname.lastname@example.org|
|Contact: Lindsey Frackiewicz, BSN 203-785-3490 email@example.com|
|United States, Massachusetts|
|Boston University Medical Center||Recruiting|
|Boston, Massachusetts, United States|
|Contact: Susan Langmore, PhD|
|Principal Investigator:||Marc Moss, MD||University of Colorado, Denver|