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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Point-of-Care Ultrasound on top of diagnosis work-up |
|
| Control | No Intervention | Usual diagnosis work-up without Point-of-Care Ultrasound |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-Care Ultrasound | Diagnostic Test | Abdominal clinician-performed Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Brau | CHD Vendée | Principal Investigator |
| Philippe Leconte | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Departemental Vendée | La Roche-sur-Yon | 85925 | France | |||
| Centre Hospitalier Universitaire de Nantes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38409086 | Derived | 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. | |
| 36153600 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 4, 2024 | |
| Reset | Aug 30, 2024 | |
| Release | Sep 19, 2024 | |
| Reset | Nov 20, 2024 | |
| Release | Nov 22, 2024 | |
| Reset | Jan 8, 2025 | |
| Release | Feb 13, 2025 | |
| Reset | Feb 13, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 4, 2024 | Aug 30, 2024 | |||
| Sep 19, 2024 |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Nantes |
| France |
| 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. |
| Nov 20, 2024 |
| Nov 22, 2024 | Jan 8, 2025 |
| Feb 13, 2025 | Feb 13, 2025 |
| D012817 | Signs and Symptoms, Digestive |