Improving Detection of Dysphagia in the CICU



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:2/14/2019
Start Date:February 3, 2019
End Date:December 15, 2019
Contact:Kelby Magennis, MPH
Email:kmagennis@phhp.ufl.edu
Phone:352-237-8632

Use our guide to learn which trials are right for you!

Improving Detection and Clinical Care of Dysphagia in Cardiac Surgical Patients

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.

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.

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.
We found this trial at
3
sites
2033 Mowry Road
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
2000 Southwest Archer Road
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials