Lung Ultrasound Versus Inferior Vena Cava Collapsibility Index for Early Prediction of Volume Overload During Transurethral Resection of Prostate

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate; Lung Ultrasound Score; Transurethral Resection (TUR) Syndrome
• Intervention / Treatment: Procedure: lung ultrasound (LUS); Procedure: IVC collapsibility index

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I: lung ultrasound (LUS) group; 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.	Procedure: lung ultrasound (LUS); 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.lung ultrasound will be used as a tool for monitoring of EVLW to identify early the subclinical pulmonary edema and ensure timely and correct diagnosis and appropriate management.
Experimental: Group II: IVC collapsibility index group; Serial assessment of IVC collapsibility will be used as a monitoring of volume overload in patients enrolled in this study.	Procedure: IVC collapsibility index; Serial assessment of IVC collapsibility will be used as a monitoring of volume overload in patients enrolled in this study. Basal IVC scanning using ultrasound will be performed before the start of the operation and serial IVC scanning will be done during the procedure every 15 minutes in the first 30 minutes, and then every 30 minutes for the rest of the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of volume overload	2 HOURS

Secondary Outcome Measures

Outcome Measure	Time Frame
ABG (PaO2 and O2 saturation)	2 HOURS

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Shereen El-Sabry, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: September 2, 2025
• First Submitted That Met QC Criteria: September 9, 2025
• First Posted (Estimated): September 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Prostate; Lung Ultrasound; Inferior Vena Cava Collapsibility Index; Overload during Transurethral Resection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Pathological Conditions, Signs and Symptoms; Syndrome
• Other Study ID Numbers: 36264MS733/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No