跳至主要内容
临床试验/NCT06333106
NCT06333106已完成不适用

PoCUS Diagnostic Accuracy for Fecal Impaction in the Emergency Department: A Prospective Study

Cliniques universitaires Saint-Luc- Université Catholique de Louvain12 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2024年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
247
试验地点
12
主要终点
Evaluation of the diagnostic value of clinical ultrasound in the diagnosis of fecal impaction in the emergency room

研究概览

简要总结

Many medical and paramedical specialties regularly use point-of-care ultrasound (PoCUS) in clinical practice. The diagnosis of fecal impaction is quite common in the elderly living in nursing homes with a prevalence of 47.3%. Fecal impaction remains a major source of morbidity, while its etiology is often multifactorial and its diagnosis challenging. Current recommendations for the diagnosis of fecal impaction support the use of plain abdominal x-rays. PoCUS is a non-irradiating procedure and a clinical diagnostic tool that can be used in a variety of ways during abdominal examinations. Most scientific societies encourage the use of PoCUS to respond to a specific clinical question rather than to provide a diagnosis, which is usually confirmed by conventional ultrasound. However, the combination of physical examination and PoCUS may improve the diagnostic approach. This multicentric prospective study protocol aims to evaluate the diagnostic accuracy of PoCUS in patients aged 75 years or older with suspected fecal impaction in the emergency department compared with plain abdominal x-ray (or abdominal CT scan if required as part of the emergency department investigations).

详细描述

Background Many medical specialties and paramedical fields are increasingly using point-of-care ultrasound (PoCUS). PoCUS is a pillar of clinical evaluation along with inspection, palpation, percussion, and auscultation, and it has become essential in daily clinical practice, as it enhances differential diagnosis. In a position statement published in 2015, the American Academy of Emergency Medicine followed by the European Federation of Societies for Ultrasound in Medicine and Biology in 2016 recommended the inclusion of PoCUS in the curricula of medical schools to improve the learning of core concepts and enhance students' understanding of physical examinations. The integration of PoCUS into clinical examination raises the issue of PoCUS diagnostic accuracy.

In everyday practice, fecal impaction is defined as the accumulation of hard fecal matter in the rectum and colon, with the absence of spontaneous evacuation. Its annual prevalence is estimated at 47.3% in nursing homes, affecting approximately 70% of nursing home patients. Furthermore, 42% of patients admitted to geriatric services suffer from fecal impaction.

In the United States, 21.9% of patients admitted to the emergency department (ED) with fecal impaction died in hospital, and severe morbidity was identified in 40.6% of patients. Over 90% of the patients with fecal impaction who visited the ED subsequently required hospitalization. In 2011, there were 42,000 ED visits in the US for fecal impaction, with patients aged over 65 being the most affected.

It is widely known that the incidence of fecal impaction increases with age and impairs quality of life in patients over 65 years of age. This common problem is often undiagnosed and thus frequently left untreated, whereas its prompt identification and treatment minimize the risk of complications. The most frequent symptoms are false diarrhea, fecal incontinence, behavioral disorders (agitation, delirium), loss of appetite, nausea, vomiting, abdominal pain, and electrolyte disorders. The site of impaction is most often rectal in 66.4% of cases. Fecal impaction is the most frequent cause of diarrhea in the elderly, with an incidence of 55%. Currently, in the ED, fecal impaction is diagnosed by plain abdominal X-rays or abdominal computed tomography (CT) scans if required as part of the ED investigations.

PoCUS is a valuable tool for investigating suspected fecal impaction, as it can guide the investigator to make a rapid diagnosis, thus leading to its rapid management. To analyze the presence of fecal impaction using PoCUS, the patient should be supine and comfortable. In the case of fecal retention in the rectal lumen, ultrasound waves are reflected from the surface of the contents at a depth deeper than the bladder (anechoic area), with a hyperechoic area with a half-moon shape being depicted in the transverse ultrasound image. In addition, with hard stool accumulation, an acoustic shadow appears in the transverse ultrasound image of the crescent-shaped hyperechoic area. By contrast, in the absence of fecal retention or gas in the rectal lumen, no obvious hyperechoic area is depicted. In the transverse ultrasound image, a circumferential hypoechoic area may be observed as an empty intestine.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
75 Years 至 130 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 75 years or older
  • Patient for whom the clinician in charge indicates that an abdominal x-ray should be performed to check for the presence of a fecal impaction
  • Informed consent, read and signed by the patient or their legal representative

排除标准

  • Patient or legal representative not understanding one of the consent languages (French, Dutch and English)
  • Reasons making suprapubic ultrasound impossible

结局指标

主要结局

Evaluation of the diagnostic value of clinical ultrasound in the diagnosis of fecal impaction in the emergency room

时间窗: 2 hours

Sensitivity and specificity of PoCUS in the diagnosis of fecal impaction compared to abdominal radiography (or abdominal CT) as a diagnostic reference tool with likelihood ratios and positive and negative predictive values.

次要结局

  • Influence of BMI on the diagnosis of fecal impaction at PoCUS(2 hours)
  • Influence of bladder repletion on the diagnosis of fecal impaction using PoCUS(2 hours)
  • Influence of patient echogenicity on the diagnosis of fecal impaction using PoCUS(2 hours)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (12)

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