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

NCT02099045 | Unknown

• 1 other identifier: DNVK1305018
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Point of Care Ultrasonography in the Emergency Department.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in diagnostics or treatments plan

  Within 2 hours after primary evaluation of the patient after the ultrasound examination has been performed.

Study Arms (1)

Ultrasound examination

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

Device: Point of Care Ultrasonography

Interventions

Point of Care Ultrasonography DEVICE

Ultrasound examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Unselected consecutive patients in the Emergency Department.

You may qualify if:

• All patients over the age of 18 presenting at the ED

You may not qualify if:

• Sonographic examination cannot be performed within the first two hours
• Failure to consent.
• Sonographical examination interferes with lifesaving treatment.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Emergency Department, Regional Hospital Herning

Herning, 7400, Denmark

RECRUITING

Related Links

• Official site for Research Center for Emergency Medicine

Study Officials

• Jesper Bo Weile, MD

  Research Center for Emergency Medicine

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Jesper Weile, MD

CONTACT

(+45)22748072; jesper.weile@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: March 28, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2017
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

DK (1)