Initial Patient Evaluation in the Emergency Department With Point-of-Care Ultrasonography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

406 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Point of Care Ultrasonography in the Emergency Department.

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ultrasound examination

All patients over the age of 18 presenting in the emergency department.

Point of Care Ultrasonography

Intervention Type DEVICE

Interventions

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Point of Care Ultrasonography

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes