Lung Ultrasound ScoreNCT07164638
Lung Ultrasound Versus Inferior Vena Cava Collapsibility Index for Early Prediction of Volume Overload During Transurethral Resection of Prostate
A study testing lung ultrasound (LUS) and IVC collapsibility index in people with Lung Ultrasound Score and Transurethral Resection (TUR) Syndrome, run by Tanta University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Lung Ultrasound Score, Transurethral Resection (TUR) Syndrome, Prostate
- What is being tested?
- lung ultrasound (LUS) and IVC collapsibility index
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male patient
- American Society of Anesthesiologists classification II-III
- scheduled for Transurethral resection of the prostate syndrome under spinal anesthesia.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Being tested
- lung ultrasound (LUS), IVC collapsibility index
- Keywords
- Lung Ultrasound, Inferior Vena Cava Collapsibility Index, Overload during Transurethral Resection, Prostate
- Medical subject headings
- Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasound (LUS)Procedure or surgery
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.
IVC collapsibility indexProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: lung ultrasound (LUS) |
| 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. Receives: Procedure: IVC collapsibility index |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of volume overload
Measured: 2 HOURS
Secondary outcomes (1)
ABG (PaO2 and O2 saturation)
Measured: 2 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start30 Oct 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Ultrasound ScoreStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Ashraf Abdelrazik El-Sabry, Tanta University
- Investigators
- Shereen El-Sabry, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164638
- Sponsor's protocol ID
- 36264MS733/11/24
- Status last verified
- Nov 2024
- First submitted
- 2 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Versus Inferior Vena Cava Collapsibility Index for Early Prediction of Volume Overload During Transurethral Resection of Prostate: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07164638
- Acronym / sponsor ID
- 36264MS733/11/24
- Keywords
- Lung Ultrasound, Inferior Vena Cava Collapsibility Index, Overload during Transurethral Resection, Prostate
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: lung ultrasound (LUS) group | Experimental | 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. |
| Group II: IVC collapsibility index group | Experimental | Procedure: IVC collapsibility indexSerial assessment of IVC collapsibility will be used as a monitoring of volume overload in patients enrolled in this study. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male patient
- American Society of Anesthesiologists classification II-III
- scheduled for Transurethral resection of the prostate syndrome under spinal anesthesia.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group I: lung ultrasound (LUS) group |
| IVC collapsibility indexSerial 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. | Procedure or surgery | Group II: IVC collapsibility index group |
Primary outcome
incidence of volume overload
Time frame: 2 HOURS
1 secondary outcome
ABG (PaO2 and O2 saturation)
Time frame: 2 HOURS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shereen El-Sabry principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung ultrasound (LUS) and IVC collapsibility index in people with Lung Ultrasound Score and Transurethral Resection (TUR) Syndrome, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of volume overload (time frame: 2 HOURS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.