Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain (EchoPAIN)
Primary Purpose
Abdominal Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Point-of-Care Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Pain focused on measuring Abdominal Pain, Point-of-Care Ultrasound
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Departemental Vendée
- Centre Hospitalier Universitaire de Nantes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Point-of-Care Ultrasound on top of diagnosis work-up
Usual diagnosis work-up without Point-of-Care Ultrasound
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04912206
First Posted
May 28, 2021
Last Updated
July 19, 2022
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT04912206
Brief Title
Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain
Acronym
EchoPAIN
Official Title
Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain, Prospective Randomized Dual Centre Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
June 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
Abdominal Pain, Point-of-Care Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Point-of-Care Ultrasound on top of diagnosis work-up
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual diagnosis work-up without Point-of-Care Ultrasound
Intervention Type
Diagnostic Test
Intervention Name(s)
Point-of-Care Ultrasound
Intervention Description
Abdominal clinician-performed Ultrasound
Primary Outcome Measure Information:
Title
Exact diagnostic rate
Description
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).
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Brau
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Leconte
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Departemental Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36153600
Citation
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.
Results Reference
derived
Learn more about this trial
Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain
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