Point of Care Ultrasonography in the Emergency Department. Clinical Trial
Official title:
Initial Patient Evaluation in the Emergency Department With Point-of-Care Ultrasonography
Background: It is well known that emergency physicians can conduct ultrasound examinations
as a supplement to initial physical examination. No previous studies have been conducted to
evaluate the total findings with ultrasound on a broad unselected group of patients in the
Emergency Department.
Aim: We aim to identify the pathology found in an unselected cohort of patients in a Rural
Emergency Department. Secondarily we aim to quantify the changes done in treatment as a
result of the ultrasound examination performed bedside in the Emergency Department.
Hypothesis: Supplemental ultrasonographical examination will change diagnostics and
treatment in 10 % of an unselected cohort of patients in the Emergency Department.
Method: We will perform a structured ultrasound examination of 406 patients on an unselected
cohort in the emergency department. All patients age 18 years and above presenting in the
emergency department will be included in the study. Patients unwilling to give informed
consent will be excluded from the study. Patients will be excluded if the ultrasonographic
examination cannot be performed within the first two hours after initial contact with the
treating physician. The study will be conducted in two substudies. Sub study 1 including all
patient legally competent to give informed consent. Sub study 2 including all legally
incompetent patients who cannot give informed consent due to acute illness. These patients
will be included in the study under the rules of emergency research.
After including the patients we will ask the treating physician a series of binary questions
regarding diagnosis and treatment plan.
Outcome: Primary outcome is the pathology found by ultrasound in the department. Secondary
outcome will be the changes in diagnosis or treatment plan. Pathology and changes in
diagnosis/treatment will be stratified according to initial complaint, triage level, age and
other factors. This has never been done on unselected patients in the Emergency Department.
Ethical considerations and adverse effects: Ultrasound transmits high frequency waves into
the tissue, which is reflected to the ultrasound probe. The time and magnitude of the
returning sound waves are interpreted into picture on the screen. No adverse effects have
been reported on the basis of the sound waves transmitted through the tissue.
Some patients might experience discomfort due to the sticky sensation from the application
of ultrasound gel. Others might experience discomfort from the pressure applied to the probe
under the imaging. Adverse effects, which we are not aware of, may exist. However, clinical
ultrasound has existed since the 1950'ies and new adverse effects are unlikely.
Publication: All results will be published in international peer-review journals. Also in
the event of inconclusive results.
| Status | Recruiting |
| Enrollment | 406 |
| Est. completion date | January 2017 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All patients over the age of 18 presenting at the ED Exclusion Criteria: - Sonographic examination cannot be performed within the first two hours - Failure to consent. - Sonographical examination interferes with lifesaving treatment. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Emergency Department, Regional Hospital Herning | Herning |
| Lead Sponsor | Collaborator |
|---|---|
| Aarhus University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pathology found by POC ultrasonography | Cardiac function. Pericardial effusion more than 3 mm. Left ventricular function: Hyper dynamic, Normal, Mildly reduced, Moderately reduced, Severely reduced. Hypertrophic left ventricle: Ventricle wall > 1,2 cm Right ventricle function: TAPSE: > 20 mm: 16-20 mm: 13-15 mm: 10-12 mm: < 10 mm. Right ventricle wall > 0,8mm Left ventricle < right ventricle. Aortic sclerosis, Visible mass in lumen, Visible papillary muscle rupture, Pathology to mitral or tricuspid valve, Other findings. Inferior Vena Cava. IVC diameter : < 10 mm,10 -15mm, 16- 20mm, > 20mm IVC respiratory variation: collapse, > 50%, <50%, none Lung ultrasound: Absence of lung sliding, Visible pleural effusion, Multiple b-lines (=3 in focal area) Abdominal ultrasound: Free fluid, Hydronephrosis: Left; Right, Gallbladder wall thickening > 4 mm Gallbladder width: > 4 cm,Murphey's sign, Visible cholecystolithiasis, Aortic aneurism: Size in cm Bladder size in ml Evaluation of the deep veins on the lower extremity for DVT | Within two hours after initial evaluation of the patient. | No |
| Secondary | Changes in diagnostics or treatments plan | Within 2 hours after primary evaluation of the patient after the ultrasound examination has been performed. | No |