Clinical trial NCT02099045: Initial Patient Evaluation in the Emergency Department With Point-of-Care Ultrasonography
Official title: Initial Patient Evaluation in the Emergency Department With Point-of-Care Ultrasonography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Point of Care Ultrasonography in the Emergency Department.
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unselected consecutive patients in the Emergency Department.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pathology found by POC ultrasonography
timeFrame: Within two hours after initial evaluation of the patient.
Secondary outcomes:
measure: Changes in diagnostics or treatments plan
timeFrame: Within 2 hours after primary evaluation of the patient after the ultrasound examination has been performed.
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Emergency Department, Regional Hospital Herning
Study officials:
affiliation: Research Center for Emergency Medicine
name: Jesper Bo Weile, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Emergency Medicine
name: Hans Kirkegaard, MD, Professor, dr.med, ph.d.
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology, Skejby University Hospital
name: Erik Sloth, MD, professor, dr.med., ph.d
role: STUDY_CHAIR
affiliation: Department of Cardiology, Aarhus University Hospital
name: Christian Alcaraz Frederiksen, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Respiratory Medicine, Odense University Hospital
name: Christian Laursen, MD
role: STUDY_CHAIR
References: