The Detection of Lung Pathologies Among Dialysis Patients Using Novel Mobile-Phone Ultrasound - A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PulseNmore
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To measure success rate and identification of pathological lung B-lines, using novel mobile phone, Pulsenmore MC device, in chronic renal failure patients, pre and post dialysis.
研究概览
简要总结
PRIMARY OBJECTIVE: To measure success rate and identification of pathological lung B-lines, using novel mobile Self-scan ultrasound device (MC, by Pulsenmore), in chronic renal failure patients, pre and post dialysis.
SECONDARY OBJECTIVE: 1.To describe the difference in B-lines score (BLS), pre and post dialysis as measured by the new device.
-
Examine the degree of agreement in the BLS performed by the new mobile , MC device to the traditional POCUS device.
-
To describe the identification rate of lung atelectasis and pleural effusion by the study device compared to standard ultrasound machine STUDY DESIGN: A prospective, pilot, single-center study. INTERVENTION: Lung point of care ultrasound (POCUS) performed with a new ultrasound device, MC based on mobile phone among chronic renal failure patients pre and post dialysis. SAMPLE SIZE CONSIDERATIONS: As this is a feasibility study sample size was not calculated, we will perform convenience sample of 30 patients.
STUDY PROCEDURES: Lung point of care ultrasound (POCUS) performed with a new MC device on chronic renal failure patients pre and post dialysis.
The following data will be collected:
- Demographic factors: age, gender, ethnicity
- Medical history: medications, diabetes mellitus, hypertension, systemic diseases, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD), height and weight
- Clinical data:
oDates of admission oTreatment: dialysis duration (years) oEssential: heart rate, blood pressure, saturation, weight. Dry weight, BMI. All before and after session
- US results- BLS detected from pictures collected by:
o the new MC device o the traditional POCUS device
- Detection of lung atelectasis by o the new MC device o the traditional POCUS device
- Detection of pleural effusion by o the new MC device o the traditional POCUS device
OUTCOMES AND ANALYSES:
- Agreement rate between the study MC device and the gold standard ultrasound machine for primary and secondary objectives.
- Time of study in each machine.
详细描述
Background Patients with end-stage renal disease (ESRD) and heart failure (HF) have a high risk to suffer from pulmonary congestion (PC) (1,2). PC in HF and ESRD patients is a common cause of admission, mortality, and cardiac events )3-6(. Extravascular lung water (EVLW), which leads to PC, can be subclinical among normo-hydrated dialysis patients (1,7).
PC exact mechanism in ESRD is under debate )8( but occurs in a combination of two forces mechanism - changes in hydrostatic pressure due to HF and volume overload and increase in lung permeability with retention of uremic product and chronic inflammation (1,2,6,8). Chronic load of extracellular volume and increased LV filling pressure is mainly the cause of EVLW accumulation leading to clinical PC (1,2). Volume overload builds gradually during the interval between the dialysis treatments (6,7) and maybe asymptomatic (1,6). PC can also occur in ESRD patients, even with normal cardiac filling pressure or mild volume overload )8( and can be explained by volume redistribution (2). Untreated or suboptimal treated PC can cause respiratory distress. Volume overload is an independent risk factor for death and cardiovascular events in ESRD patients (2,9). Therefore, volume removal is crucial to prevent PC events (2). Dialysis reduces the severity of PC immediately )8(, and delay in treatment can increase the frequency and the severity of the events (8,9).
Lung ultrasound (LUS) is an effective, bedside, imaging tool for the detection and monitoring of PC (2,7-12). Alveolar interstitial syndrome, which can be caused by an increase of EVLW, is diagnosed by the detection of ultrasonographic B-lines in both lung zones (2,3,5,7,9,10). Lung ultrasound was found at least sensitive and effective as other traditional modalities to diagnose PC (1,4,5,8,10,13).
B-lines are hyperechoic reverberation, relatively simple to teach and conduct (3,8,11), which can be detected by LUS (5,8,14). Some studies quantified B-lines using the B-line score (BLS). The score is calculated by the number of lung zones that are dichotomously positive for B-lines (10,11). Furthermore, B-lines are an important prognostic factor for death, cardiovascular events, and readmission in ESRD and HF patients (2-4,10-12).
Changes in BLS seen during volume removal by dialysis treatment or diuresis (2,7-10) represents the dynamic changes in EVLW (7,9-11). Studies found a distinct real-time decrease in the number of B-line and BLS that correlated with the traditional examination for EVLW (2,9- 11,13). Data suggests that B-lines monitoring is used for the assessment of volume overload removal adequacy (2,4,10,11).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •Patients diagnosed with End-stage renal disease (ESRD) and treated with chronic dialysis center at Soroka University Medical Center (SUMC)
- •Cognitive intact and can sign informed consent as decided by their treating nephrologist.
- •have smart phone and any social app- like WhatsApp- his or her main care giver
排除标准
- •Morbid obese - BMI>35
- •History of lung resection or lung transplant.
结局指标
主要结局
To measure success rate and identification of pathological lung B-lines, using novel mobile phone, Pulsenmore MC device, in chronic renal failure patients, pre and post dialysis.
时间窗: 10 months
To measure success rate and identification of pathological lung B-lines, using novel mobile phone, Pulsenmore MC device, in chronic renal failure patients, pre and post dialysis.
次要结局
- To describe the difference in B-lines score (BLS), pre and post dialysis as measured by the new device, Pulsenmore MC(10 months)
- Examine the degree of agreement in the BLS performed by the new mobile Pulsenmore MC device to the traditional ultrasound device.(10 months)
- To describe the identification rate of lung atelectasis and pleural effusion by the study(10 months)
