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

NCT ID: NCT04912206

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2022-06-23

Brief Summary

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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.

Detailed Description

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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.

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

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Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Point-of-Care Ultrasound

Intervention Type DIAGNOSTIC_TEST

Abdominal clinician-performed Ultrasound

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Point-of-Care Ultrasound

Abdominal clinician-performed Ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Brau

Role: PRINCIPAL_INVESTIGATOR

CHD Vendée

Philippe Leconte

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Centre Hospitalier Departemental Vendée

La Roche-sur-Yon, , France

Site Status

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 38409086 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36153600 (View on PubMed)

Other Identifiers

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CHD20_0133

Identifier Type: -

Identifier Source: org_study_id

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