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Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain (EchoPAIN)

C

Centre Hospitalier Departemental Vendee

Status

Completed

Conditions

Abdominal Pain

Treatments

Diagnostic Test: Point-of-Care Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT04912206
CHD20_0133

Details and patient eligibility

About

Non-traumatic abdominal pain is one of the most frequent complaints in Emergency Medicine. Point-of-Care Ultrasound (POCUS) has good performance in these situations. It is performed at the patient's bedside with immediate results. It has been demonstrated that a clinician-performed ultrasound was able to increase the diagnosis accuracy in patients with acute abdominal pain. However, the level of evidence of its diagnostic efficacy remains controversial in particular in Europe.

The principal investigators thus aimed to investigate the efficacy of early POCUS on diagnostic accuracy in the context of of non-traumatic abdominal pain by a randomized control study conducted in two emergency departments (ED). Secondary objectives will be comparison between the two groups for time spent in the ED before diagnosis and disposition (discharged home or hospitalization), prescription of complementary examinations and in particular, radiologic exams.

Full description

Non-traumatic abdominal pain is one of the most frequent complaints in Emergency Medicine. Point-of-Care Ultrasound (POCUS) has good performance in these situations. It is performed at the patient's bedside with immediate results. It has been demonstrated that a clinician-performed ultrasound was able to increase the diagnosis accuracy in patients with acute abdominal pain.

The principal investigators thus aimed to investigate the efficacy of early POCUS on diagnostic accuracy in the context of of non-traumatic abdominal pain by a randomized control study conducted in two ED. Secondary objectives will be comparison between the two groups for time spent in the ED before diagnosis and disposition (discharged home or hospitalization), prescription of complementary examinations and in particular, radiologic exams.

It will be a randomized, controlled, open and interventional study. In the control group, the diagnosis will be established after clinical examination and reception of biological analysis results. In the interventional group, a POCUS performed in the ED by a local investigator will be added and the diagnosis will be established after clinical exam, biological analysis reception and POCUS. POCUS will only be performed by physicians who have completed a validated training program.

Furthermore, before study initiation, refresh sessions focused on acquisition techniques and pathological findings will be organized in the two participating ED. Such refresher courses were efficient to increase the overall confidence of operators

Enrollment

256 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients older than 18 years
  • Admitted for acute abdominal pain lasting for less than 5 days
  • Availability in the ED at that time of an Emergency Physician trained in POCUS
  • Patient able to understand the protocol and having given oral informed consent to participate in the study or included under the emergency inclusion procedure

Exclusion criteria

  • Documented end-of-life with a do-not-resuscitate order
  • Immediate need for management for hemodynamic stabilization
  • Patient sent to the ED by an out-of-hospital practitioner
  • Pregnant and breast-feeding women
  • No social security
  • Under guardianship, curatorship or deprived of liberty.
  • Do not understand French

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

256 participants in 2 patient groups

Intervention
Experimental group
Description:
Point-of-Care Ultrasound on top of diagnosis work-up
Treatment:
Diagnostic Test: Point-of-Care Ultrasound
Control
No Intervention group
Description:
Usual diagnosis work-up without Point-of-Care Ultrasound

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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