"Point of Care" Ultrasound and Renal Colic (ECHOLINE)

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

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:

1. Abdominal x-ray/Ultrasound or non-injected scanner for simple forms to be performed within 24-48h
2. 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.

Study Overview

• Status: Unknown
• Conditions: Renal Colic
• Intervention / Treatment: Procedure: Ultrasound; Other: Standard care

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amélie Lansiaux, MD, PhD; Phone Number: 0033 0320225269; Email: lansiaux.amelie@ghicl.net
• Study Contact Backup: Name: Jean-Jacques Vitagliano; Phone Number: 0033 0320225751; Email: vitagliano.jean-jacques@ghicl.net

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • GHICL
    • Contact: Hervé Duga, MD; Phone Number: 0033 03 20 87 45 09; Email: duga.herve@ghicl.net
    • Principal Investigator: Hervé Duga, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ultrasound	Procedure: Ultrasound; 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
OTHER: Standard care	Other: Standard care; Standard clinical care of patients. In regards of the clinical evolution and of biological results, a CT scan could be performed by the physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Duga Hervé, MD, GHICL

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 7, 2019
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: ultrasound; point of care; emergency room; renal colic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Renal Colic; Colic
• Other Study ID Numbers: RC-P0072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No