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

Abdominal Pain Clinical Trial

— EchoPAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912206
• Other study ID #: CHD20_0133
• Status: Completed
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: June 23, 2022

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdomen, Acute
• Abdominal Pain
• Emergencies

Intervention

Diagnostic Test:
• Point-of-Care Ultrasound
Abdominal clinician-performed Ultrasound

Locations

Country	Name	City	State
France	Centre Hospitalier Departemental Vendée	La Roche sur Yon
France	Centre Hospitalier Universitaire de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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