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临床试验/NCT07164638
NCT07164638Enrolling By Invitation不适用

Lung Ultrasound Versus Inferior Vena Cava Collapsibility Index for Early Prediction of Volume Overload During Transurethral Resection of Prostate: A Prospective Observational Study

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
incidence of volume overload

研究概览

简要总结

The aim of this study is to compare between accuracy of lung US and IVC CI for early prediction of volume overload during TURP.

Primary outcome:

The incidence of volume overload during transurethral resection of prostate.

详细描述

Benign prostatic hyperplasia and its associated symptoms affect many men worldwide, the prevalence is over 210 million men. Up to 50% of men over the age of 50 and up to 80% of men over the age of 80 experience lower urinary tract symptoms from Benign prostatic hyperplasia. Transurethral resection of the prostate is considered the gold standard treatment for prostatic hyperplasia. Small amounts of irrigation fluid are absorbed through the prostatic sinuses in almost every Transurethral resection of the prostate operation. Circulating one liter of irrigation within one hour results in an acute decrease in serum sodium concentration from five to eight mmol/L and may indicate an increased risk of Transurethral resection of the prostate syndrome. Both hypertension and hypotension can be observed in TURP syndrome. Hypertension and reflex bradycardia are explained by rapid volume expansion reaching 200 mL/min. Patients also may develop pulmonary edema due to acute circulatory overload. Transurethral resection of the prostate syndrome is a complication characterized by a change in symptoms from asymptomatic hyponatremia to fatigue, vomiting, confusion, loss of vision, Electrocardiogram changes, seizures, coma, and death. It usually happens due to absorption of irrigation fluid during Transurethral resection of the prostate . This syndrome is related to the amount of fluid entering the circulation through the blood vessels or excessive absorption in the resection area. Increased systolic pressure elevates the left ventricular after load, resulting in heart failure or pulmonary edema, which is characterized by dyspnea, hypoxia, tachypnea and crackles on chest auscultation. Studies have shown that symptomatic heart failure occurs in 1.1% of Transurethral resection of the prostate cases, with severe pulmonary edema occurring in 0.3%. Pulmonary edema is a serious complication of Transurethral resection of the prostate and a common cause of death. The incidence of Transurethral resection of the prostate syndrome is about 3.8% following Transurethral resection of the prostate for Benign prostatic hyperplasia. Most of the studies reports similar incidence of this complication of Transurethral resection of the prostate syndrome in a range of 0-10%. Classic methods for clinical assessment of the patient capacity status, such as central venous pressure monitoring, the Flotrac/Vigileo system, are all invasive and carry risks such as hematoma, pneumothorax, infection, and embolism. In recent years, some non-invasive capacity assessment techniques have been gradually applied, such as lung ultrasound and the inferior vena cava collapsibility index. The aim of this study is to compare between accuracy of lung ultrasound score and inferior vena cava collapsibility index for early prediction of volume overload during TURP.

Primary outcome:

The incidence of volume overload during transurethral resection of prostate.

Secondary outcomes:

The incidence of transurethral resection of prostate.

研究设计

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

入排标准

性别
Male
接受健康志愿者
否

入选标准

  • •Male patient
  • •American Society of Anesthesiologists classification II-III
  • •scheduled for Transurethral resection of the prostate syndrome under spinal anesthesia.

排除标准

  • •Patient refusal.
  • •Uncooperative patients.
  • •Patients with major respiratory, cardiac, renal or hepatic disorders.
  • •Patients whose ultrasound did not clearly show the inferior vena cava as (morbidly obese patients or patients with moderate to marked ascites).
  • •Patients who have contraindications to spinal anesthesia (neurological disease, severe hypotension, coagulopathy, low fixed cardiac output).

研究组 & 干预措施

Group I: lung ultrasound (LUS) group

Experimental

Serial lung ultrasound will be performed to patients enrolled in this study before the beginning of the surgery, every 15 minutes in the first 30 minutes, and then every 30 minutes for the rest of the operation.

干预措施: lung ultrasound (LUS) (Procedure)

Group II: IVC collapsibility index group

Experimental

Serial assessment of IVC collapsibility will be used as a monitoring of volume overload in patients enrolled in this study.

干预措施: IVC collapsibility index (Procedure)

结局指标

主要结局

incidence of volume overload

时间窗: 2 HOURS

次要结局

  • ABG (PaO2 and O2 saturation)(2 HOURS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shereen Ashraf Abdelrazik El-Sabry

Resident

Tanta University

研究点 (1)

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