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临床试验/NCT07126847
NCT07126847进行中(未招募)不适用

Evaluation of the Success of POCUS Usage in Addition to STONE Criteria in Diagnosing Nephrolithiasis and Predicting Readmission Within One Month in Patients Presenting to the Emergency Department With Suspected Nephrolithiasis

Kocaeli City Hospital1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
490
试验地点
1
主要终点
Nephrolithiasis diagnostic accuracy

研究概览

简要总结

Patients presenting to the emergency department with symptoms suggestive of renal colic will be included in the study at Kocaeli City Hospital's emergency department. Patients with nephrolithiasis considered among the preliminary diagnoses will be enrolled in the study; demographic data, vital signs, and physical examination findings will be recorded on pre-prepared standard data forms.

STONE criteria scores will be calculated by emergency assistants, and bedside ultrasound will be performed for patients. Ultrasonographic findings suggestive of renal colic, such as hydronephrosis, the presence of primary stones, acoustic shadowing of the stone, the presence of twinkle artifact, presence of jet flow, and presence of bladder debris, will be evaluated, and the obtained data will be recorded on the standard data form by the performing assistant physician. In patients where computed tomography, which is the gold standard for detecting stone presence without intervention, is deemed appropriate without any intervention to the primary examining physician, the computed tomography results and ultrasound findings will be compared.

The study aims to evaluate the effectiveness of bedside ultrasound application in diagnosing stone presence in patients, its success in predicting re-admission to the hospital within 1 month, its success in predicting possible alternative diagnoses and complications, in addition to the stone criteria applied in the patients.

详细描述

Our study is a prospective study that will be conducted in the Emergency Medicine Clinic of Kocaeli City Hospital. Patients aged 18 and above who present to the emergency department of Kocaeli City Hospital with symptoms suggestive of renal colic will be included in the study if they volunteer. After examination by a resident physician working in the emergency department, patients for whom nephrolithiasis is considered among the preliminary diagnoses will be notified to the principal investigators. After obtaining written consent, demographic data, vital signs, and physical examination findings will be recorded on previously prepared standard data forms.

Patients scoring 8 points or higher according to the STONE criteria based on history, physical examination, and laboratory results will undergo bedside ultrasound. The ultrasound will be performed by 4 resident physicians with a basic ultrasound course certificate from the Turkish Emergency Medicine Association, who have 2 years of experience. The bedside urinary ultrasound will be performed using the 'Esaote Mylab Gamma® device (Genoa, Italy)' ultrasound machine with the 'Esaote AC2541 curved array (1-8 MHz) probe (Genoa, Italy)' while the patient is in the supine position.

During renal ultrasound, the convex ultrasound probe will be placed in the right upper quadrant of the patient, intersecting the right lower intercostal area and the mid-axillary line. In the left upper quadrant, the probe will be placed in the lower intercostal area along the posterior axillary line. The ultrasound probe will be positioned longitudinally with the indicator pointing towards the patient's head. Subsequently, the same area will be imaged transversely with the indicator pointing towards the patient's right.

In these sections, images of the kidneys will be evaluated for the presence of hydronephrosis, the degree of expansion of pelvic-calyceal structures, stone size, kidney dimensions, parenchymal echogenicity, and the presence of primary stones or acoustic shadowing from stones. Then, from the suprapubic region, the probe will be positioned transversely and longitudinally, sequentially showing the patient's right and head; the presence of globules in the bladder, bladder dimensions, the presence of stones, and the degree of jet flow at the junction of the ureters with the bladder will be assessed using color frequency mode (CFM). The presence of twinkling artifacts with color frequency mode (CFM) will be evaluated when a stone is suspected. The data obtained will be recorded on the study form by the resident physician performing the ultrasound. The recorded data will later be compared with the gold standard diagnostic method, computed tomography routinely performed in patients with nephrolithiasis, for effectiveness.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All volunteer patients

排除标准

  • Pregnant patients,
  • Patients for whom the clinician does not give an indication for computed tomography,
  • Patients with a previous history of nephrectomy and kidney transplantation.

结局指标

主要结局

Nephrolithiasis diagnostic accuracy

时间窗: 2 year

Adding bedside focused ultrasonography to the STONE criteria increases diagnostic accuracy in patients presenting to the emergency department with a preliminary diagnosis of nephrolithiasis.

次要结局

  • Predicting the possible complications(2 year)
  • Readmission to hospital.(1 month)

研究者

发起方
Kocaeli City Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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