Point-of-care Ultrasound in Finland

NCT03327688 | Completed

• 1 other identifier: KUH507T027
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

Brief Summary

This study has two aims.

1. 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.
2. 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.

Conditions

Deep Vein Thrombosis; Abdominal Aortic Aneurism; Pneumothorax; Gallbladder Diseases; Hydronephrosis; Pregnancy, Ectopic; Ascites; Pleural Effusion; Pericardial Effusion

Keywords

Focus assesment with sonography for trauma; POCUS; LOS; Point-of-care ultrasound; length of stay; cost-minimization; primary health care; Ultrasound; Emergency department

Outcome Measures

Primary Outcomes (1)

• Length of stay in emergency department

  time between registration in emergency department and "finished from doctor" sign.

  Duration of a single emergency department visit. Up to 48 hours.

Secondary Outcomes (2)

• Need for follow-up radiologist performed imaging

  6 months

• Accuracy of POCUS exam findings

  6 months

Study Arms (4)

POCUS group

ACTIVE COMPARATOR

Point-of-care ultrasound

Diagnostic Test: Point-of-care ultrasound

Radiologist group

NO INTERVENTION

Traditional diagnostic way

DVT POCUS group

ACTIVE COMPARATOR

DVT group after POCUS education

Diagnostic Test: Point-of-care ultrasound

DVT traditional group

NO INTERVENTION

DVT group traditional diagnostic way before educational intervention

Interventions

Point-of-care ultrasound DIAGNOSTIC_TEST

Point-of-care ultrasound performed by an emergency physician

DVT POCUS group; POCUS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ossi Hannula: lead
• University of Eastern Finland: collaborator

Study Sites (4)

Central Finland central hospital

Jyväskylä, 40620, Finland

Location

Kuopio university hospital

Kuopio, 70210, Finland

Location

Saarikka Primary Care Public Utility

Saarijärvi, 43100, Finland

Location

Tampere university hospital

Tampere, Finland

Location

Related Publications (9)

• Bernstein SL, Aronsky D, Duseja R, Epstein S, Handel D, Hwang U, McCarthy M, John McConnell K, Pines JM, Rathlev N, Schafermeyer R, Zwemer F, Schull M, Asplin BR; Society for Academic Emergency Medicine, Emergency Department Crowding Task Force. The effect of emergency department crowding on clinically oriented outcomes. Acad Emerg Med. 2009 Jan;16(1):1-10. doi: 10.1111/j.1553-2712.2008.00295.x. Epub 2008 Nov 8.

  PMID: 19007346 BACKGROUND

• Ross M, Brown M, McLaughlin K, Atkinson P, Thompson J, Powelson S, Clark S, Lang E. Emergency physician-performed ultrasound to diagnose cholelithiasis: a systematic review. Acad Emerg Med. 2011 Mar;18(3):227-35. doi: 10.1111/j.1553-2712.2011.01012.x.

  PMID: 21401784 BACKGROUND

• Rubano E, Mehta N, Caputo W, Paladino L, Sinert R. Systematic review: emergency department bedside ultrasonography for diagnosing suspected abdominal aortic aneurysm. Acad Emerg Med. 2013 Feb;20(2):128-38. doi: 10.1111/acem.12080.

  PMID: 23406071 BACKGROUND

• Stein JC, Wang R, Adler N, Boscardin J, Jacoby VL, Won G, Goldstein R, Kohn MA. Emergency physician ultrasonography for evaluating patients at risk for ectopic pregnancy: a meta-analysis. Ann Emerg Med. 2010 Dec;56(6):674-83. doi: 10.1016/j.annemergmed.2010.06.563. Epub 2010 Sep 15.

  PMID: 20828874 BACKGROUND

• Park YH, Jung RB, Lee YG, Hong CK, Ahn JH, Shin TY, Kim YS, Ha YR. Does the use of bedside ultrasonography reduce emergency department length of stay for patients with renal colic?: a pilot study. Clin Exp Emerg Med. 2016 Dec 30;3(4):197-203. doi: 10.15441/ceem.15.109. eCollection 2016 Dec.

  PMID: 28168226 BACKGROUND

• Wilson SP, Connolly K, Lahham S, Subeh M, Fischetti C, Chiem A, Aspen A, Anderson C, Fox JC. Point-of-care ultrasound versus radiology department pelvic ultrasound on emergency department length of stay. World J Emerg Med. 2016;7(3):178-82. doi: 10.5847/wjem.j.1920-8642.2016.03.003.

  PMID: 27547276 BACKGROUND

• Alrajab S, Youssef AM, Akkus NI, Caldito G. Pleural ultrasonography versus chest radiography for the diagnosis of pneumothorax: review of the literature and meta-analysis. Crit Care. 2013 Sep 23;17(5):R208. doi: 10.1186/cc13016.

  PMID: 24060427 BACKGROUND

• Birdwell BG, Raskob GE, Whitsett TL, Durica SS, Comp PC, George JN, Tytle TL, McKee PA. The clinical validity of normal compression ultrasonography in outpatients suspected of having deep venous thrombosis. Ann Intern Med. 1998 Jan 1;128(1):1-7. doi: 10.7326/0003-4819-128-1-199801010-00001.

  PMID: 9424975 BACKGROUND

• Ten Cate-Hoek AJ, Toll DB, Buller HR, Hoes AW, Moons KG, Oudega R, Stoffers HE, van der Velde EF, van Weert HC, Prins MH, Joore MA. Cost-effectiveness of ruling out deep venous thrombosis in primary care versus care as usual. J Thromb Haemost. 2009 Dec;7(12):2042-9. doi: 10.1111/j.1538-7836.2009.03627.x. Epub 2009 Sep 28.

  PMID: 19793189 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Pneumothorax; Gallbladder Diseases; Hydronephrosis; Pregnancy, Ectopic; Ascites; Pleural Effusion; Pericardial Effusion; Emergencies

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pleural Diseases; Respiratory Tract Diseases; Biliary Tract Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pregnancy Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Disease Attributes

Study Officials

• Harri Hyppölä, docent

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, emergency medicine resident

Model Details: 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

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 31, 2017
• Study Start: October 20, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

FI (4)