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

July 19, 2022 updated by: Centre Hospitalier Departemental Vendee

Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain, Prospective Randomized Dual Centre Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Departemental Vendée
      • Nantes, France
        • Centre Hospitalier Universitaire de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Point-of-Care Ultrasound on top of diagnosis work-up
Diagnostic test: Point-of-Care Ultrasound
Abdominal clinician-performed Ultrasound
No Intervention: Control
Usual diagnosis work-up without Point-of-Care Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exact diagnostic rate
Time Frame: The reference diagnosis will be determined by an adjudication committee on the basis of an exhaustive analysis of the patient's file at Day 28
Comparison of the rate of exact diagnostic after clinical exam and biological results with point-of-care ultrasound (interventional arm) or without (control arm) according to the adjudication committee diagnostic (reference diagnosis).
The reference diagnosis will be determined by an adjudication committee on the basis of an exhaustive analysis of the patient's file at Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Principal Investigator: François Brau, CHD Vendee
  • Principal Investigator: Philippe Leconte, CHU Nantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Actual)

June 23, 2022

Study Completion (Actual)

June 23, 2022

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD20_0133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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