Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05319379 |
| Other study ID # |
22020104-IRB01 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
January 3, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: Dyspnea, like pain, is subjective and challenging to assess despite the large
number of patients that report shortness of breath. Several studies have shown that
physicians and nurses inaccurately assess patient dyspnea. Since respiratory therapists care
for many patients at risk for dyspnea, an evaluation of their abilities to evaluate dyspnea
is needed. Thus, the plan is to evaluate respiratory therapists' ability to assess a
patient's dyspnea level, in addition to nurses and physicians.
Methods: This is a prospective study to evaluate the agreement between dyspnea assessment by
a patient and respiratory therapist, nurses, and physicians. The primary aim of this study
will be to evaluate clinician ability to assess a patients dyspnea level. The secondary aim
of this study is to identify patient characteristics that might influence clinician ability
to assess dyspnea.
Description:
According to the American Thoracic Society (ATS), the term dyspnea characterizes the
subjective experience of breathing discomfort of patients. Dyspnea, like pain, is subjective.
Currently, there is no single standard evaluation of dyspnea despite the large number of
tools designed to help patients accurately quantify patients who report breathing
discomfort.2 Many patients report dyspnea, and studies have shown significant physiological
responses associated with breathing discomfort. For example, the amygdala is activated with
dyspnea and elicits a sense of impending doom. This is concerning because the prevalence of
dyspnea varies widely, from as high as 65% in lung cancer patients to as low as 16% in
low-risk population. It appears that the prevalence of dyspnea varies vastly between disease
processes, but it not clear if clinicians are able to accurately detect breathing discomfort
on routine assessments.
Various efforts have been made to understand how well physicians and nurses assess the
dyspnea status of patients. In 2017, Binks et al assessed physicians, nurses, and respiratory
therapists on their ability to rate dyspnea in patients requiring mechanical ventilation. The
study found that those patients experienced dyspnea and at a significantly higher prevalence
than any professional had rated. There was also positive correlation between the amount of
discomfort and the degree of underestimation, thus undertreatment which can lead to patient
suffering. In a prospective observational study conducted by Puntillo et al, 171 patients
considered high risk of dying were assessed for symptoms experienced while in the intensive
care unit (ICU). In that study, they found that a significant number of patients had
unaddressed symptoms that contributed to unnecessary suffering. Dyspnea was found to be the
most distressing symptom that patients experienced. Interestingly, dyspnea was noted in
patients that required mechanical ventilation and those that did not.
Stefan et al conducted a study to evaluate the agreement of dyspnea in spontaneously
breathing patients with that of the physicians or nurses' assessment. The researchers found
that physicians underestimated patients' dyspnea 37.9 % of the time and overestimated 25.8%
while nurses underestimated 43.5% and overestimated 12.4%. This is worrisome considering the
number of patients that suffer from dyspnea.
Several studies have shown that clinicians responsible for respiratory assessments, like
physicians and nurses, often inaccurately assess breathing discomfort. Since respiratory
therapists care for many patients at risk for dyspnea, an evaluation of their abilities to
assess it should be made. Findings from a study involving respiratory therapists, along with
findings from other medical professionals, will provide valuable information for future
efforts to better train clinicians on how to best assess dyspnea. The primary aim of this
study will be to evaluate clinician (respiratory therapist, nurse, and physician) ability to
assess patient dyspnea level. The secondary aims of this study are to identify patient
characteristics that might influence clinician ability to assess dyspnea.
