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

NCT04912206 | Completed

• 1 other identifier: CHD20_0133
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Abdominal Pain

Keywords

Abdominal Pain; Point-of-Care Ultrasound

Outcome Measures

Primary Outcomes (1)

• Exact diagnostic rate

  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

Study Arms (2)

Intervention

EXPERIMENTAL

Point-of-Care Ultrasound on top of diagnosis work-up

Diagnostic Test: Point-of-Care Ultrasound

Control

NO INTERVENTION

Usual diagnosis work-up without Point-of-Care Ultrasound

Interventions

Point-of-Care Ultrasound DIAGNOSTIC_TEST

Abdominal clinician-performed Ultrasound

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (2)

Centre Hospitalier Departemental Vendée

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

Related Publications (2)

• Brau F, Papin M, Batard E, Abet E, Frampas E, Le Thuaut A, Montassier E, Le Bastard Q, Le Conte P. Impact of emergency physician performed ultrasound in the evaluation of adult patients with acute abdominal pain: a prospective randomized bicentric trial. Scand J Trauma Resusc Emerg Med. 2024 Feb 26;32(1):15. doi: 10.1186/s13049-024-01182-5.

  PMID: 38409086 DERIVED

• Brau F, Martin S, Le Bastard Q, Ricaud P, Legrand A, Montassier E, Le Conte P. Impact of emergency physician-performed ultrasound for the evaluation of patients with acute abdominal pain, prospective randomized dual Centre study: study protocol for a diagnostic trial. Trials. 2022 Sep 24;23(1):804. doi: 10.1186/s13063-022-06755-2.

  PMID: 36153600 DERIVED

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• François Brau

  CHD Vendée

  PRINCIPAL INVESTIGATOR

• Philippe Leconte

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: June 11, 2021
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)