NCT04429698

Brief Summary

Background: When used with standard diagnostic testing, point-of-care ultrasonography (POCUS) might improve the proportion of patients admitted with chest pain (CP) who are correctly diagnosed, decrease length of stay (LOS) in emergency department (ED) and costs. We therefore assessed POCUS for the heart, lungs, aortic, hepatobiliary and deep vein in addition to the usual initial diagnostic testing in this patient population. Methods: In a prospective, randomised-controlled, parallel-group trial in the ED at Sakarya University Training and Research Hospital, Turkey, patients (≥18 years) with CP were randomly assigned in a 1:1 ratio to a standard diagnostic strategy (control group) or to standard diagnostic strategy supplemented with POCUS (POCUS group).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

June 5, 2020

Last Update Submit

June 11, 2020

Conditions

Keywords

chest pain, POCUS, length of stay, emergency department

Outcome Measures

Primary Outcomes (2)

  • Duration of hospitalization or discharge

    6 months

  • Average costs during the diagnosis of patients.

    6 months

Secondary Outcomes (3)

  • The rate of change in the preliminary diagnosis of physician

    6 months

  • The Hospitalization rate

    6 months

  • The discharge rate

    6 months

Study Arms (2)

POCUS group

OTHER

Patients in this group underwent POCUS after primary clinical evaluation with the knowledge of their primary physician. This procedure was performed in the first hour after the patients' primary clinical evaluations to evaluate the predetermined parameters in the study form for the heart, lungs, hepatobiliary, aortic and deep veins.

Diagnostic Test: Point of care ultrasonography

Control group

NO INTERVENTION

All processes and results were followed without any intervention in the processes related to the patients in this group and the results were recorded in the study form

Interventions

Point-of-care Ultrasonography is an imaging method performed with ultrasound aid to facilitate rapid diagnosis and interventions during emergency intervention.

POCUS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the emergency were included in this study if they had chest pain, or chest pain with back pain, neck and jaw pain, abdominal pain, arm pain and shortness of breath

You may not qualify if:

  • permanent mental disability
  • age younger than 18 years
  • having chest trauma in the last 24 hours
  • to be pregnant
  • need for urgent angiography with ST elevation myocardial infarction
  • to be referred to the ED as a diagnosis of external center
  • failure to obtain complete patient information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, 54050, Turkey (Türkiye)

Location

Related Publications (5)

  • Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.

    PMID: 30413369BACKGROUND
  • Laursen CB, Sloth E, Lassen AT, Christensen Rd, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Point-of-care ultrasonography in patients admitted with respiratory symptoms: a single-blind, randomised controlled trial. Lancet Respir Med. 2014 Aug;2(8):638-46. doi: 10.1016/S2213-2600(14)70135-3. Epub 2014 Jul 3.

  • Lamsam L, Gharahbaghian L, Lobo V. Point-of-care Ultrasonography for Detecting the Etiology of Unexplained Acute Respiratory and Chest Complaints in the Emergency Department: A Prospective Analysis. Cureus. 2018 Aug 28;10(8):e3218. doi: 10.7759/cureus.3218.

  • Elikashvili I, Tay ET, Tsung JW. The effect of point-of-care ultrasonography on emergency department length of stay and computed tomography utilization in children with suspected appendicitis. Acad Emerg Med. 2014 Feb;21(2):163-70. doi: 10.1111/acem.12319.

  • Lin MJ, Neuman M, Rempell R, Monuteaux M, Levy J. Point-of-Care Ultrasound is Associated With Decreased Length of Stay in Children Presenting to the Emergency Department With Soft Tissue Infection. J Emerg Med. 2018 Jan;54(1):96-101. doi: 10.1016/j.jemermed.2017.09.017. Epub 2017 Oct 27.

MeSH Terms

Conditions

Chest PainEmergencies

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Necip G Guner, M.D.

    Sakarya University Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principial Investigator

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 12, 2020

Study Start

September 15, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

June 12, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations