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Point-of-care Ultrasound in Finland

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ClinicalTrials.gov Identifier: NCT03327688
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by (Responsible Party):
Ossi Hannula, Kuopio University Hospital

Brief Summary:

This study has two aims.

  1. Deep venous thrombosis (DVT) is a common suspected medical condition. If it cannot be excluded clinically and using D-dimer, ultrasound examination is required. An option for traditional radiologist-performed ultrasound is a 2-point compression ultrasound (2-CUS). The safety of this technique is proven. However there does not exist any data on costs comparing traditional and 2-CUS pathways in primary health care. This study will evaluate the total cost of both pathways by conducting a cost-minimization analysis. It will also study the effect of a simple ultrasound education on the referrals to hospital due to suspected DVT.

    Hypothesis 1: Short education in ultrasound will reduce significantly referrals to hospital and save resources.

  2. Length of stay (LOS) in emergency department (ED) is related to increased mortality, morbidity, prolonged hospital stay and probably patient satisfaction. LOS of patients with a point-of-care ultrasound (POCUS) performed by an emergency physician (EP) will be compared to those that have a radiology performed ultrasound examination. Further examination and accuracy of POCUS will be noted.

Hypothesis 2: POCUS can shorten LOS significantly in selected clinical conditions


Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Abdominal Aortic Aneurism Pneumothorax Gallbladder Diseases Hydronephrosis Pregnancy, Ectopic Ascites Pleural Effusion Pericardial Effusion Diagnostic Test: Point-of-care ultrasound Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Part 1: All referrals to hospital due to a suspected DVT before intervention in year 2014, vs all referrals due to a suspected DVT after intervention in year 2017.

Part 2: POCUS group vs radiologist group

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Point-of-care Ultrasound in Finland
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: POCUS group
Point-of-care ultrasound
Diagnostic Test: Point-of-care ultrasound
Point-of-care ultrasound performed by an emergency physician

No Intervention: Radiologist group
Traditional diagnostic way
Active Comparator: DVT POCUS group
DVT group after POCUS education
Diagnostic Test: Point-of-care ultrasound
Point-of-care ultrasound performed by an emergency physician

No Intervention: DVT traditional group
DVT group traditional diagnostic way before educational intervention



Primary Outcome Measures :
  1. Length of stay in emergency department [ Time Frame: Duration of a single emergency department visit. Up to 48 hours. ]
    time between registration in emergency department and "finished from doctor" sign.


Secondary Outcome Measures :
  1. Need for follow-up radiologist performed imaging [ Time Frame: 6 months ]
    If radiologist performed ultrasound exam is required, is it performed the same day, during same hospital day or later by appointment. Does the POCUS examination lead to other imaging modality while skipping radiologist performed ultrasound exam.

  2. Accuracy of POCUS exam findings [ Time Frame: 6 months ]
    POCUS findings are compared to any follow-up imaging by radiologist, surgery results or autopsy results when possible



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Emergency department patient
  • A suspected medical condition, that can be confirmed or excluded by basic POCUS exam, including: free fluid in pleura, pericardium or intraperitoneal space, abdominal aorta aneurysm, gallbladder stones, urine retention, deep venous thrombosis in lower limb, pneumothorax, early pregnancy with non-specified location (confirming intrauterine pregnancy), hydronephrosis.
  • Emergency medicine specialist or resident decides to perform a POCUS exam

Exclusion Criteria:

  • age under 18
  • not able to give informed consent in Finnish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327688


Contacts
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Contact: Ossi Hannula, MD +356 17 173311 ossi.hannula@ksshp.fi

Locations
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Finland
Central Finland central hospital Recruiting
Jyväskylä, Finland, 40620
Contact: Ossi Hannula, MD    +358 17 173311    ossi.hannula@ksshp.fi   
Sub-Investigator: Juho Liukkonen, MD         
Principal Investigator: Ossi Hannula, MD         
Kuopio university hospital Recruiting
Kuopio, Finland, 70210
Contact: Ossi Hannula, MD    +358 17 173311    ossi.hannula@ksshp.fi   
Principal Investigator: Ossi Hannula, MD         
Sub-Investigator: Harri Hyppölä, Docent         
Saarikka Primary Care Public Utility Completed
Saarijärvi, Finland, 43100
Tampere university hospital Not yet recruiting
Tampere, Finland
Contact: Ossi Hannula         
Sub-Investigator: Ossi Hannula, MD         
Principal Investigator: Satu-Liisa Pauniaho, MD, PhD         
Sponsors and Collaborators
Ossi Hannula
University of Eastern Finland
Investigators
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Principal Investigator: Harri Hyppölä, docent Kuopio University Hospital

Publications:

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Responsible Party: Ossi Hannula, MD, emergency medicine resident, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT03327688     History of Changes
Other Study ID Numbers: KUH507T027
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ossi Hannula, Kuopio University Hospital:
Focus assesment with sonography for trauma
POCUS
LOS
Point-of-care ultrasound
length of stay
cost-minimization
primary health care
Ultrasound
Emergency department

Additional relevant MeSH terms:
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Pleural Effusion
Aneurysm
Thrombosis
Aortic Aneurysm
Venous Thrombosis
Aortic Aneurysm, Abdominal
Ascites
Pneumothorax
Hydronephrosis
Pericardial Effusion
Gallbladder Diseases
Pregnancy, Ectopic
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Aortic Diseases
Pleural Diseases
Respiratory Tract Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Heart Diseases
Biliary Tract Diseases
Digestive System Diseases
Pregnancy Complications