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.

Study Overview

• Status: Unknown
• Conditions: Point of Care Ultrasonography in the Emergency Department.
• Intervention / Treatment: Device: Point of Care Ultrasonography

• Study Type: Observational
• Enrollment (Anticipated): 406

Contacts and Locations

• Study Contact: Name: Jesper Weile, MD; Phone Number: (+45)22748072; Email: jesper.weile@gmail.com

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • Recruiting
    • Emergency Department, Regional Hospital Herning
    • Contact: Jesper Bo Weile, MD; Phone Number: (+45)22748072
    • Principal Investigator: Jesper B. Weile, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Unselected consecutive patients in the Emergency Department.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasound examination; All patients over the age of 18 presenting in the emergency department.	Device: Point of Care Ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in diagnostics or treatments plan	Within 2 hours after primary evaluation of the patient after the ultrasound examination has been performed.

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Principal Investigator: Jesper Bo Weile, MD, Research Center for Emergency Medicine; Study Chair: Hans Kirkegaard, MD, Professor, dr.med, ph.d., Research Center for Emergency Medicine; Study Chair: Erik Sloth, MD, professor, dr.med., ph.d, Department of Anaesthesiology, Skejby University Hospital; Study Chair: Christian Alcaraz Frederiksen, MD, PhD, Department of Cardiology, Aarhus University Hospital; Study Chair: Christian Laursen, MD, Department of Respiratory Medicine, Odense University Hospital

Publications and helpful links

Helpful Links

• Official site for Research Center for Emergency Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: March 26, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 28, 2014

Study Record Updates

• Last Update Posted (Estimate): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: DNVK1305018