ClinicalTrials.gg
Enrolling by invitationNCT07164638Updated Sep 10, 2025

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

An interventional study of lung ultrasound (LUS) and IVC collapsibility index in Lung Ultrasound Score, Transurethral Resection (TUR) Syndrome and Prostate, sponsored by Tanta University. Enrolling by invitation at 1 site in Egypt. Open to male participants. Per ClinicalTrials.gov, last updated 2025-09-10.

Primary conditionnone(registry's first term: Syndrome)No conditionIs this wrong?Syndrome describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Tanta University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as enrolling by invitation.
  • Registered 10 months after the study started (first participant enrolled Oct 2024, registered Sep 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Lung Ultrasound Score
  • Transurethral Resection (TUR) Syndrome
  • Prostate

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Keywords

  • Lung Ultrasound
  • Inferior Vena Cava Collapsibility Index
  • Overload during Transurethral Resection
  • Prostate
03

In context

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 to spinal anesthesia (neurological disease, severe hypotension, coagulopathy, low fixed cardiac output).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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)

  • 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

Interventions

  • Procedurelung 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.

  • ProcedureIVC 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.

06

What researchers measure

Primary outcomes

  1. incidence of volume overload

    Time frame: 2 HOURS

Secondary outcomes

  1. ABG (PaO2 and O2 saturation)

    Time frame: 2 HOURS

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07164638
Lead sponsor
Tanta University
Responsible party
Shereen Ashraf Abdelrazik El-Sabry (Resident, Tanta University) — Principal investigator
First posted
Sep 10, 2025
Start date
Oct 30, 2024
Primary completion
Oct 30, 2025 (estimated)
Completion
Oct 30, 2025 (estimated)
Last update
Sep 10, 2025

Study contacts

Shereen El-Sabry
principal investigator · Tanta University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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