NCT07164638

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

September 10, 2025

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

September 2, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Lung UltrasoundInferior Vena Cava Collapsibility IndexOverload during Transurethral ResectionProstate

Outcome Measures

Primary Outcomes (1)

  • incidence of volume overload

    2 HOURS

Secondary Outcomes (1)

  • ABG (PaO2 and O2 saturation)

    2 HOURS

Study Arms (2)

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.

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.

Procedure: IVC collapsibility index

Interventions

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.

Group I: lung ultrasound (LUS) group

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.

Group II: IVC collapsibility index group

Eligibility Criteria

Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Syndrome

Condition Hierarchy (Ancestors)

DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shereen El-Sabry

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 10, 2025

Study Start

October 30, 2024

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

September 10, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations