Point of Care Ultrasound and Renal Colic

Study Overview
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Brief Summary
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The management of renal colic in emergency departments follows the recommendations established at the 8th consensus conference of 2008 on the management of renal colic in emergency services. It recommends the control of pain by nonsteroidal anti-inflammatory drugs and analgesics, the implementation of an urinary test strip and the use of emergency imaging for compiled forms and patient with medical specificities. Currently, two imaging techniques are recommended during an episode of renal colic: Abdominal x-ray/Ultrasound or non-injected scanner for simple forms to be performed within 24-48h The non-injected scanner for complicated forms In simple forms, the decision to perform any examination remains at the discretion of the physician but with a tendency to carry out a scanner systematically even in the absence of criteria of severity or complication. The use of the scanner exposes the patient to large doses of radiation even if it is a low dose scanner. In recent years, studies have been conducted to determine whether the ultrasound, particularly point of care ultrasound performed by an emergency physician could be an alternative in the management of renal colic. Studies show that the sensitivity and specificity of ultrasound is comparable to that of the scanner. It has been found that the performance of an ultrasound by the emergency physician allows the decrease in irradiation and also in costs. In 2014,a study published in the New England Journal of Medicine emphasized that the ultrasound performed by the emergency physician would perform just as well as that performed by the radiologist and would result in a decreased time in the emergency room. The Korean study, published in 2016 in the Clinical and Experimental Emergency Medicine (CEEM), despite some statistical inconsistencies, shows a significant reduction in the time of care by 74 minutes. In this context, we would like to conduct a single-centre, randomised, controlled, open-label study comparing a group of patients benefiting from point of care ultrasound versus a group of patients not benefiting from it. The goal is to determine whether the early ultrasound performed by the emergency physician by detecting expansions of the pelvicalyceal cavities reduces the time spent in the emergency department.

Official Title
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Impact of the Use of Point of Care Ultrasound on the Length of Stay in the Emergency Department During an Episode of Renal Colic

Conditions
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Renal Colic

Intervention / Treatment
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* Procedure: Ultrasound
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients admitted in ER for suspicion of simple renal colic Signed informed consent Exclusion Criteria: protected adults (tutorship or guardianship) fever ≥ 38.5°C chronic endstage kidney failure (Glomerular filtration rate < 30%) Solitary kidney Urinary tract catheter or percutaneous nephrectomy Pregnancy traumatic back pain Renal colic diagnosis in the past three months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br> | Procedure: Ultrasound<br>* The emergency physician will perform a point of care ultrasound. If signs of expansions of the pelvicalyceal cavities are found, an early CT scan will follow<br>|
| Other: Standard care<br> | Other: Standard care<br>* Standard clinical care of patients. In regards of the clinical evolution and of biological results, a CT scan could be performed by the physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between admission and discharge from the emergency room |  | Day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients satisfaction scale | 5 questions to be answered by the patients rated on 1-10 scales being equivalent to 1 being equivalent to no, certainly not and 10 being equivalent to yes, certainly yes . An overall score of 50 will be calculated to assess patient satisfaction. | An average of 24 hours | 
| Physician satisfaction scale | 5 questions to be answered by the physicians rated on 1-10 scales being equivalent to 1 being equivalent to no, certainly not and 10 being equivalent to yes, certainly yes . An overall score of 50 will be calculated to assess physician satisfaction. | 9 months | 
| Ultrasound diagnostic performance to detect expansions of the pelvicalyceal cavities | The diagnostic performance of the ultrasound for the detection of dilation of pyelocalicial cavities will be evaluated by sensitivity and specificity. The Gold Standard will be the result of the scanner | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, renal colic, emergency room, point of care