Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Detection of Dysphagia in the CICU

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: NCT03768739
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Dysphagia is a known complication to cardiac procedures, but risk factors for who will develop post-operative dysphagia remain unclear. The proposed study seeks to improve clinical care by identifying risk factors for post-operative dysphagia to inform best practice guidelines. It further seeks to improve post-operative assessment practices with the creation and internal validation of a dysphagia screening tool to improve early detection and management of dysphagia in cardiac surgical patients.

Condition or disease Intervention/treatment
Cardiac Disease Procedure: Fiberoptic Endoscopic Evaluation of Swallowing Device: Peak Cough Flow Device: Reflex Cough Testing Behavioral: 3-ounce Water Swallow Test Behavioral: Secretion Management Behavioral: Dysphonia Status Procedure: Vitals

Detailed Description:

Cardiovascular diseases account for one third of all deaths in the world and will be responsible for an estimated 25 million deaths in 2020 alone.1 Heart surgery is therefore one of the most common therapeutic procedures performed to correct, reconstruct, or replace this life-sustaining organ. An increasingly reported consequence from cardiac procedures is the development of post-operative dysphagia, likely due to mechanical trauma to motor and sensory functions of the upper aerodigestive tract and related to endotracheal intubation and/or transesophageal echocardiogram insertion, positioning, or removal.1-3 Indeed, post-operative dysphagia following cardiac surgery has been reported in up to 67% of cases4 and associated with delayed oral intake; increased risk of dehydration and malnutrition; increased hospital-acquired pneumonia; reintubation; increased length of hospital stay; mortality; and increased economic burden.5-8 Furthermore, pneumonia was recognized as the leading cause of mortality after open heart surgery9 and post-extubation dysphagia in the Intensive Care Unit (ICU) confers an annual estimated cost of over $500 million in the U.S.10

These factors necessitate identification of individuals pre-operatively who may be at a greater risk for the subsequent development of post-operative dysphagia, as well as identification of surgical and clinical practice patterns that may increase or exacerbate potential dysphagia risk. Although dysphagia is a known complication to cardiac procedures, risk factors for who will develop post-operative dysphagia remain unclear (Knowledge Gap 1).

The prevalence and associated sequelae of post-operative dysphagia also necessitate sensitive and accurate clinical screening tools for early identification of swallowing impairments during recovery and appropriate and timely care (e.g., timing to oral diet or other therapeutic interventions). Currently, no validated dysphagia screening tools exist for the cardiac ICU (CICU) and a set of sensitive clinical markers to detect swallowing impairment are yet to be determined. Although nursing and speech language pathology are responsible for the assessment of deglutition, currently no practice guidelines exist for the evaluation of swallowing in the intensive care hospital setting.11 Consequently, assessment practice patterns are highly variable with sub-optimal practice patterns and patient outcomes (Knowledge Gap 2).

The current proposal seeks to directly address these gaps in knowledge and clinical care by seeking to identify risk factors for dysphagia following cardiac surgery, identifying simple markers to reliably detect swallowing impairment and developing a swallowing screening tool to detect dysphagia in CICU post-extubated patients.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Detection and Clinical Care of Dysphagia in Cardiac Surgical Patients
Actual Study Start Date : February 3, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CICU extubated patients
Participants enrolled in this group will undergo a screening that includes: Fiberoptic Endoscopic Evaluation of Swallowing (FEES), Peak Cough Flow Reflex Cough Testing, 3-ounce Water Swallow Test, Secretion Management, Dysphonia Status, and Vitals.
Procedure: Fiberoptic Endoscopic Evaluation of Swallowing
This procedure involves a flexible laryngoscope that contains a light source and video camera on the end through the open passages of your nose and to the back of the throat in order to visualize the swallowing mechanism.
Other Name: FEES

Device: Peak Cough Flow
A peak cough flow meter will be used to assess voluntary cough strength and function.
Other Name: Voluntary Cough Function

Device: Reflex Cough Testing
A handheld nebulizer (device that transforms liquid in to breathable mist) will deliver a citric vapor for participants to breath in and out for up to 15 seconds.

Behavioral: 3-ounce Water Swallow Test
Participant will drink 3 ounces (90 cc) of room temperature water continuously from a cup without stopping.

Behavioral: Secretion Management
Research clinician will subjectively assess the presence of saliva.

Behavioral: Dysphonia Status
A subjective rating of vocal quality

Procedure: Vitals
Respiratory status and vital signs to include: oxygen saturation levels, respiratory rate, blood pressure, and heart rate.




Primary Outcome Measures :
  1. Penetration Aspiration Scale [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    This scale is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The development and use of an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events are described. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled.

  2. Yale Residue Severity Rating Scale [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    This scale is a validated measure used by trained blinded clinicians to assign ratings of efficiency to swallowing bolus trials. The Yale Pharyngeal Residue Severity Rating Scale was developed, standardized, and validated to provide reliable, anatomically defined, and image-based assessment of post-swallow pharyngeal residue severity as observed during fiberoptic endoscopic evaluation of swallowing (FEES). It is a five-point ordinal rating scale based on residue location (vallecula and pyriform sinus) and amount (none, trace, mild, moderate, and severe)

  3. New Zealand Secretion Scale [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    This scale is a validated measure used by trained blinded clinicians to assign ratings of secretion management to swallowing bolus trials. Validated eight-point scale used to assess location, amount, and response to pharyngo-laryngeal secretions. Scored 0-7; 0 being 'no airway invasion' and 7 being 'silent aspiration below the level of the vocal cords'.


Secondary Outcome Measures :
  1. Secretion Management [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    A binary bedside rating (impaired vs. normal) of secretion management will be assessed and defined as follows:Impaired: Noted drooling of saliva at rest or pooling of secretions in the oral cavity. Normal: No drooling of saliva at rest or pooling of secretions in the oral cavity.

  2. Dysphonia Status [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    A binary bedside rating (impaired vs. normal) of secretion management will be assessed and defined as follows: Impaired: Abnormal voice quality noted (aphonic, weak, hoarse, altered quality). Normal: No perceptual abnormalities in voice quality.

  3. Peak Cough Flow [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    Voluntary peak cough flow testing will be used to capture the volume of air expelled in the 1st second of cough as measured in PEF and FEV1.

  4. Reflex Cough Motor Test [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    Pass/fail reflexive cough testing using a citric vapor to assess individual's cough motor threshold. Pass score equal to or >2 cough responses; Fail score equal to or <1 cough response.

  5. Urge To Cough Sensory Test [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    Reflexive cough testing using a citric vapor to assess individual's cough sensory threshold. Scored on an 11 point scale with 0 being 'none at all' and 10 being 'very severe'.

  6. 3-ounce Water Swallow Test [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]

    This test is used as a screen for aspiration that has been validated in a general hospital setting. The participant will be asked to drink 3 ounces (90cc) of room temperature water continuously from a cup without stopping.

    This is a pass/fail screening test. Fail criteria includes: coughing or throat clearing during or immediately following administration of liquids, or the inability to drink the entire 90cc of liquid continuously.


  7. Vitals--oxygen levels [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    Sp02 (Oxygen Saturation Levels ) > 90% without support

  8. Vitals--respiratory [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    Respiratory Rate > 30

  9. Vitals--blood pressure [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    Blood Pressure Spike in blood pressure or overt signs of distress

  10. Vitals--heart rate [ Time Frame: Day 1, 2-8 hours post extubation in the ICU ]
    Heart Rate (beats per minute)



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
230 individuals undergoing cardiothoracic surgery will be enrolled in this study.
Criteria

Inclusion Criteria:

  • adults aged 18 - 90 years old
  • undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy requiring cardiopulmonary bypass
  • willing to participate in post-operative swallowing evaluation testing

Exclusion Criteria:

  • Patients undergoing exclusively transcatheter valves
  • Patients undergoing exclusively thoracic endovascular aortic repair procedures
  • The inability to achieve appropriate alertness and cognitive status following procedure will exclude one from completing the study.
  • Participants must pass cognition, respiratory and physical abilities screening to ensure testing safety.

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 ClinicalTrials.gov identifier (NCT number): NCT03768739


Contacts
Layout table for location contacts
Contact: Kelby Magennis, MPH 352-237-8632 kmagennis@phhp.ufl.edu
Contact: Justine Allen, MS 352-273-8632 j.allen@ufl.edu

Locations
Layout table for location information
United States, Florida
Cardiovascular Clinic at UF Health UF Recruiting
Gainesville, Florida, United States, 32610
UF Health at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Thoracic and Cardiovasscular Surgery at UF Health Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Layout table for investigator information
Principal Investigator: Emily Plowman, PhD University of Florida

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03768739     History of Changes
Other Study ID Numbers: IRB201802740
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Dysphagia
Extubation
Cardiac Intensive Care Unit (CICU)
Forced Expiratory Volume in One second (FEV1)
Peak Expiratory Flow (PEF)

Additional relevant MeSH terms:
Layout table for MeSH terms
Deglutition Disorders
Heart Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Cardiovascular Diseases