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

Primary Purpose

Renal Colic

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound
Standard care
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Colic focused on measuring ultrasound, renal colic, emergency room, point of care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GHICLRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ultrasound

Standard care

Arm Description

Outcomes

Primary Outcome Measures

Time between admission and discharge from the emergency room

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
November 5, 2019
Last Updated
November 18, 2019
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT04169555
Brief Title
"Point of Care" Ultrasound and Renal Colic
Acronym
ECHOLINE
Official Title
Impact of the Use of "Point of Care" Ultrasound on the Length of Stay in the Emergency Department During an Episode of Renal Colic
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
ultrasound, renal colic, emergency room, point of care

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound
Arm Type
Experimental
Arm Title
Standard care
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard clinical care of patients. In regards of the clinical evolution and of biological results, a CT scan could be performed by the physician.
Primary Outcome Measure Information:
Title
Time between admission and discharge from the emergency room
Time Frame
Day one
Secondary Outcome Measure Information:
Title
Patients satisfaction scale
Description
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.
Time Frame
An average of 24 hours
Title
Physician satisfaction scale
Description
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.
Time Frame
9 months
Title
Ultrasound diagnostic performance to detect expansions of the pelvicalyceal cavities
Description
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
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Lansiaux, MD, PhD
Phone
0320225269
Ext
0033
Email
lansiaux.amelie@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Jacques Vitagliano
Phone
0320225751
Ext
0033
Email
vitagliano.jean-jacques@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duga Hervé, MD
Organizational Affiliation
GHICL
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHICL
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé Duga, MD
Phone
03 20 87 45 09
Ext
0033
Email
duga.herve@ghicl.net
First Name & Middle Initial & Last Name & Degree
Hervé Duga, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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"Point of Care" Ultrasound and Renal Colic

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