Point of Care Ultrasonography in the Emergency Department.NCT02099045
Initial Patient Evaluation in the Emergency Department With Point-of-Care Ultrasonography
An observational study of Point of Care Ultrasonography in the Emergency Department., run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Point of Care Ultrasonography in the Emergency Department.
- What is being tested?
- Point of Care Ultrasonography
- Type of treatment
- Medical device
- How many people
- 406 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Unselected consecutive patients in the Emergency Department.
Who may be able to join
- All patients over the age of 18 presenting at the ED
Who cannot join
- Sonographic examination cannot be performed within the first two hours
- Failure to consent.
- Sonographical examination interferes with lifesaving treatment.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Emergency Department, Regional Hospital Herning
Herning, 7400
Jesper Bo Weile, MD, (+45)22748072
Jesper B. Weile, MD
About this study
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.
Read more
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.
- Being tested
- Point of Care Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care UltrasonographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound examination | All patients over the age of 18 presenting in the emergency department. Receives: Device: Point of Care Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within two hours after initial evaluation of the patient.
Secondary outcomes (1)
Changes in diagnostics or treatments plan
Measured: Within 2 hours after primary evaluation of the patient after the ultrasound examination has been performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Point of Care Ultrasonography in the Emergency Department.Studies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Weile, Aarhus University Hospital
- Investigators
- Jesper Bo Weile, MD, Principal investigator, Research Center for Emergency MedicineHans Kirkegaard, MD, Professor, dr.med, ph.d., Study chair, Research Center for Emergency MedicineErik Sloth, MD, professor, dr.med., ph.d, Study chair, Department of Anaesthesiology, Skejby University HospitalChristian Alcaraz Frederiksen, MD, PhD, Study chair, Department of Cardiology, Aarhus University HospitalChristian Laursen, MD, Study chair, Department of Respiratory Medicine, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099045
- Sponsor's protocol ID
- DNVK1305018
- Status last verified
- Jan 2015
- First submitted
- 26 Mar 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Patient Evaluation in the Emergency Department With Point-of-Care Ultrasonography
- ClinicalTrials.gov ID
- NCT02099045
- Acronym / sponsor ID
- DNVK1305018
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound examination | – | Device: Point of Care UltrasonographyAll patients over the age of 18 presenting in the emergency department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Unselected consecutive patients in the Emergency Department.
Key inclusion criteria (1 listed)
- All patients over the age of 18 presenting at the ED
Key exclusion criteria (3 listed)
- Sonographic examination cannot be performed within the first two hours
- Failure to consent.
- Sonographical examination interferes with lifesaving treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of Care Ultrasonography | Device | Ultrasound examination |
Primary outcome
Pathology found by POC ultrasonography
Time frame: Within two hours after initial evaluation of the patient.
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
1 secondary outcome
Changes in diagnostics or treatments plan
Time frame: Within 2 hours after primary evaluation of the patient after the ultrasound examination has been performed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Official site for Research Center for Emergency MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Bo Weile, MD principal investigator
Research Center for Emergency Medicine
Hans Kirkegaard, MD, Professor, dr.med, ph.d. study chair
Research Center for Emergency Medicine
Erik Sloth, MD, professor, dr.med., ph.d study chair
Department of Anaesthesiology, Skejby University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Point of Care Ultrasonography in the Emergency Department., run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesper Weile, MD ((+45)22748072, jesper.weile@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathology found by POC ultrasonography (time frame: Within two hours after initial evaluation of the patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.