Clinical Trials Directory

Trials / Completed

CompletedNCT04912206

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
256 (actual)
Sponsor
Centre Hospitalier Departemental Vendee · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPoint-of-Care UltrasoundAbdominal clinician-performed Ultrasound

Timeline

Start date
2021-06-11
Primary completion
2022-06-23
Completion
2022-06-23
First posted
2021-06-03
Last updated
2022-07-20

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04912206. Inclusion in this directory is not an endorsement.